10/27/2012. [ Safe Handling of. Hazardous Drugs. Objectives

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1 [ Safe Handling of Hazardous Drugs Objectives Discuss the history of safe handling Identify the exposure risks and routes associated with handling of hazardous drugs Review the current guidelines on the safe handling of hazardous drugs Describe the evidence of exposure risks including genotoxicity of hazardous drugs Describe and identify safe handling practices to protect the health care worker from exposure to hazardous drugs Review the current clinical evidence on the use of closed system drug transfer devices 2 What is the Issue? Many healthcare workers are frequently exposed to hazardous drugs Numerous published studies document the presence of hazardous medications in the workplace Multiple independent studies have documented hazardous drugs (HDs) in the urine of healthcare workers Exposure and uptake present serious hazards to health and safety 3 1

2 Who is Advocating for Protection? Advent of modern day chemotherapy First case report of occupational exposure risk to HDs American Society of Hospital Pharmacists Technical Advisory Bulletin (TAB) on handling cytotoxic and hazardous drugs Risk defined for occupational exposure to HDs OSHA Technical Manual Update: Controlling occupational exposure to HDs NIOSH Alert: Preventing occupational exposure to antineoplastic and other HDs in healthcare settings USP <797>: Pharmaceutical compounding Sterile preparations European Commission: Occupational Health and Safety Risks in the Healthcare Sector WA State Legislation: NIOSH definition 2014 requirement First review of carcinogenic potential of anticancer drugs First published guidelines for handling HDs American Medical First US Association evaluation of guidelines for HDs PhaSeal OSHA Technical Manual: Controlling occupational exposure to HDs American Society of Health-System Pharmacists guidelines on handling HDs DHHS NIOSH Medical surveillance for health care workers exposed to HDs 4 How are Workers Exposed? Standard safe handling protocols may not prevent exposure Healthcare workers can be exposed through: CONTAMINATED AIR (Aerosols and vapors) CONTAMINATED SURFACES (Direct contact with drugs) CONTAMINATED PPE (Hand to mouth contamination) 5 What s the Concern? Exposure to hazardous drugs is a proven danger Hazardous drugs have at least one of these characteristics: 1 Carcinogenicity Teratogenicity/developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Antineoplastic and other hazardous drugs can cause: Cancer Unusual cell development Reproductive issues Organ damage Damage to DNA (chromosomes) 6 2

3 How Serious is the Issue? The same mechanisms that chemotherapy uses to kill cancer cells also works to damage healthy cells. Hazardous drugs such as life-saving chemotherapy can be the only option for patients. However, chemo is poison by design. It is a descendant of deadly mustard gas. 7 A Parallel: Radiation Exposure Experience proves that no amount of radiation exposure can be considered entirely risk free 2 Discovery of radioactivity First studies linking radiation to cancer First reported radiation injury - burns First guidelines to limit radiation exposure Marie and Pierre Curie were awarded the 1903 Nobel Prize in physics for their work on radioactivity. Safety standards are now finally in place 8 How Pervasive is the Issue? Contamination is widespread and prevalent More than 2/3 of all areas are contaminated where drugs are prepared and administered. Surface and air contamination found despite use of biological safety cabinets. Workers and even patients can be exposed Surface Contamination with Antineoplastic Agents 3 Surface Contamination of Chemotherapy Preparation Areas in Hospital Pharmacy 4 9 3

4 10/27/2012 Joint Statement Stresses the Issue Recently OSHA, Joint Commission, NIOSH urged facilities to take a leadership role in worker safety and health:5 Every day in healthcare settings across America, workers are exposed to hundreds of powerful drugs used for cancer chemotherapy, antiviral treatments, hormone regimens and other therapies. While these drugs are used to relieve and heal patients, many of them present serious hazards to the health and safety of your workers. Some of these drugs have been known to cause cancer, reproductive and developmental problems, allergic reactions and other adverse effects that can be irreversible even after low-level exposure. 10 What are the Risks? The Personal Reality Nurses, pharmacists and others who handle chemo drugs have been getting sick. Despite multiple studies that indicate the drugs actually may cause cancers, the federal government doesn't require safeguards on the job. Lifesaving drugs may be killing health workers

5 Short-Term Health Risks Occupational exposure can lead to acute symptoms 7 HEADACHES MUCOSAL SORES LIVER DAMAGE HAIR LOSS DIZZINESS NAUSEA/VOMITING 13 Long-Term Health Risks Prolonged exposure can lead to irreversible adverse effects CANCER GENETIC ORGAN REPRODUCTIVE DEVELOPMENTAL 14 Cancer Risks Fact: Hazardous drugs can lead to increased rates of cancer 15 5

6 Reproductive Risks Fact: Hazardous drugs can cause reproductive problems Nurses who handle cancer drugs 11 have: - 70% more birth defects - 10% more miscarriages Incidence of miscarriages among nurses working with antineoplastic drugs is twice the norm Developmental, Organ and Genetic Risks Fact: Hazardous drugs can harm developing fetuses Handling of cytostatic drugs was associated with malformations in the offspring. 13 Fact: Hazardous drugs can damage internal organs Three consecutive head nurses handling cytostatic agents had liver damage. 14 Fact: Hazardous drugs can damage DNA Pharmacists and nurses who handle antineoplastic drugs have a 2.5 to 5-fold increase in chromosomal aberrations. 15 Increase in Chromosomal Aberrations 17 Genetic Risks Fact: Healthcare workers using standard safety precautions still have DNA damage Increased aberrations are seen on Chr 5, 7 and 11 signature markers for many leukemias and myelodyspastic syndromes. 16 Standard Safety Measures Aren t Enough 18 6

7 What are the Options? How do We Protect the Providers? ISOPP recommends following Hierarchic Order of Protection: Industrial Hygiene Model Level 1: Elimination, substitution, replacement Level 2: Isolation of the hazard/source containment Level 3: Engineering controls/ventilation Level 3B: Administrative controls/organization methods Level 4: Personal Protective equipment First choice: Stop hazardous drug use. Second choice: Isolate the drug. 20 Administrative Controls Defining Hazardous Drugs in the facility Policies and Procedures addressing all aspects of handling hazardous drugs: - Safe storage - Transport - Administration - Disposal of HD s All employees handling HDs should be required to wear PPE* Policies should prohibit eating, drinking, smoking, chewing gum or tobacco, applying cosmetics and storing food in areas HDs are used Training and documentation of training for all employees that may come in contact with HDs Spills should be managed according to HD spill policy and procedure 7

8 Work Practice Controls Designed to minimize occupational exposure to HDs Minimize the generation of HD contamination and maximize the containment of inadvertent contamination Similar to administrative controls as they are established procedures Consistent and appropriate use of engineering controls and PPE Work Practice Controls Work Practice Controls Avoid spiking and un-spiking bags or bottles Disconnect and discard infusion bags with tubing intact Place HD disposal containers near the workplace Keep the lid closed on HD disposal containers Avoid touching equipment when wearing gloves used to handle HDs Use PPE when stocking HDs Clean countertops and other surfaces in the work area Use a CSTD when working with HDs 8

9 Personal Protective Equipment Gloves: Designated Chemotherapy Gloves, thickness, type and time worn are major determinants of permeability of HDs For drugs to be labeled for use with chemotherapy they must be tested on the following drugs: Carmustine,Cyclophoshamide,Doxorubicin,Etoposide, 5-FU,Paclitaxel and Thiotepa Gowns: No standard exists to test for permeability Cloth gowns do not provide adequate protection Gowns with polyethylene and vinyl coatings performed the best in a study conducted (Harrison and Kloos, 1999) Gowns should be changed after each use and not re-used or saved Personal Protective Equipment Eye and Facial Protection Respiratory protection - Surgical mask is not a respirator and does not protect against aerosols or vapors - Fit tested NIOSH approved N95 respirator or more protective respirator should be worn Is Technology the Answer? There are many choices but also many myths Biological Safety Cabinet Barrier Isolator Closed System Transfer Device 27 Compounding Robot Filter Devices 9

10 What is a CSTD? Nothing Out: Protects healthcare workers from the dangers of hazardous drug exposure Nothing In: Prevents microbial ingress, maintaining sterility of the vial contents 28 Technology Comparison Closed Systems Closed System Transfer Device (as defined by NIOSH) FILTER vs. Cytotoxic drug molecule 29 Do CSTDs Really Work? Elimination of human uptake Using a CSTD to Reduce Personnel Exposure to Antineoplastic Agents 23 Workplace Contamination with Antineoplastic Agents in a Cancer Hospital Using a CSTD. 24 BD PhaSeal 3 rd party, peer-reviewed, published clinical studies Validate clinical efficacy Show elimination of human uptake 30 * As tested on human samples 10

11 Do CSTDs Really Work? Reduction in surface contamination % Reduction of Positive Surface Samples 25 Comparison of Surface Contamination with Cyclophosphamide and Fluorouracil: CSTD vs. Standard Preparation 26 Surface contamination before the use of CSTD Cyclophosphamide - 78% Ifosfamide - 54% 5-FU - 33% 31 What is the Evidence for CSTDs? Clinical Evidence Summary Extensive clinical evidence from dozens of independent, peer-reviewed, published studies clearly documents the effectiveness of CSTDs. Results Only BD PhaSeal met the NIOSH and ISOPP definition of a CSTD. 27 Only BD PhaSeal met the NIOSH and ISOPP definition of a CSTD. 28 No leakage was observed in any of the manipulations with the BD PhaSeal system. 29 Post implementaition, no positive urine samples. Post implementaition, no positive urine samples. Median values demonstrated reduction for all drugs (cyclophosphamide, ifosfamide, 5-FU) of 95%, 90% & 65% respectively. Demonstrated protection outside of a biological safety cabinet. Summary Titanium tetrachloride was selected to simulate the escape of vapor from each product. Fluorescein sodium was selected to simulate contamination with dry connections between the vial and syringe and between syringe and access port. Liquid with low ph was used as a substitute for active drug. Litmus paper was used as a ph indicator. Every component was tested for 10 manipulations. Surface contamination with and personnel exposure to antineoplastic agents before and after the implementation of a CSTD. Determined levels of environmental chemotherapy contamination in a new cancer hospital that had exclusively used a CSTD (BD PhaSeal). 114 wipe study samples selected from 22 hospitals. Determined surface contamination of a CSTD in conjunction with standard preparation outside a BSC 32 Who has Endorsed CSTDs? CSTDs are defined and endorsed by recognized organizations NIOSH Definition A drug transfer device that mechanically prohibits the transfer of environmental contamination into the system and the escape of hazardous drug or vapor concentrations outside the system. Revised USP <797> Guidelines USP <797> states that CSTDs are vial transfer devices that allow no venting or exposure of hazardous substance to the environment and that The use of a CSTD is preferred because of their inherent closed-system process. 30 OSHA, The Joint Commision, NIOSH Recommendations from OSHA, The Joint Commission and NIOSH to follow the 2004 NIOSH Alert for Hazardous Drugs. ASHP Excerpts: CSTDs mechanically prevent the escape of drug or vapor out of the system Studies show reduction in environmental contamination Consider using CSTDs while compounding hazardous drugs 31 ONS Excerpt: ONS (2005) The PhaSeal System is the only documented closed system on the market. This system is designed to prevent leakage of drugs into the environment during preparation and administration * BD PhaSeal also meets ISOPP and APHON guidelines and definitions 11

12 10/27/2012 The Future of HD Legislation? Washington State bill unanimously passed the senate and house33 Department of Labor and Industries must establish standards for the handling of antineoplastic and other hazardous drugs by health care personnel in consultation with the Department of Health Must describe drugs to be regulated, exposure control program for handling, engineering controls, safe work practices, use of PPE, notices to employees, emergency response, record keeping and any other requirements to protect the health and safety of health care personnel Rules adopted and go into effect January 1, The Time for Safety is Now! Safe Handling Today Many healthcare workers are still exposed to harmful effects Handling of hazardous drugs in healthcare requires a systematic approach While use of engineering controls and standard personal protective equipment (PPE) has increased, state regulation is limited; federal legislation is non-existent However, use of CSTDs as a form of PPE is increasing nationwide Comprehensive safe-handling programs should begin with a hazard assessment and include multiple layers of protection including a CSTD CSTDs that meet the NIOSH and ISOPP definitions can reduce human uptake by: - Preventing drug exposure - Reducing surface contamination 36 12

13 References 1. NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings National Institute for Occupational Safety and Health. DHHS (NIOSH) Publication No ; Radiation and risk a hard look at the data; a brief history of radiation. Los Alamos Science. 1995;23: , Connor TH, Anderson RW, Sessink PJ, Broadfield L, Power LA. Surface contamination with antineoplastic agents in six cancer treatment centers in Canada and the United States. Am J Health Syst Pharm. 1999;56(14): Siderov J, Kirsa S, McLauchlan R. Surface Contamination of Cytotoxic Chemotherapy Preparation Areas in Australian Hospital Pharmacy Departments. Journal of Pharmacy Practice and Research. 2009;39(2): April 4, 2011 Communication from Dr. David Michaels, Asst. Sec. Labor, OSHA; Dr. Paul Schyve, Sr. VP, The Joint Commission, Dr. John Howard, Director NIOSH. 6. Smith C. Lifesaving drugs may be killing health workers. Seattle Times. July 10, Valanis BG, Vollmer WM, Labuhn KT, Glass AG. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nurs. 1993;16(4): Skov T, Maarup B, Olsen J, et al. Leukaemia and reproductive outcome among nurses handling antineoplastic drugs. Br J Ind Med. 1992;49(12): Hansen J, Olsen JH. Cancer morbidity among Danish female pharmacy technicians. Scand J Work Environ Health.1994;20(1): Buchbinder R, Barber M, Heuzenroeder L, et al. Incidence of Melanoma and Other Malignancies Among Rheumatoid Arthritis Patients Treated with Methotrexate. Arthritis Rheum. 2008;59(6): Lawson CC, Rocheleau CM, Whelan EA. Occupational exposures among nurses and risk of spontaneous abortion. Am J Obstet Gynecol. 2012;206(4):327.e1-8. Epub 2011 Dec Nurses Health and Workplace Exposures to Hazardous Substances. Study conducted by Environmental Working Group, Health Care Without Harm, American Nurses Association, Environmental Health Education University of Maryland School of Nursing. Accessed at: Hemminki K, Kyronen P, Lindbohm ML. Spontaneous abortions and malformations in the offspring of nurses exposed to anaesthetic gases, cytostatic drugs, and other potential hazards in hospitals, based on registered information of outcome. J Epidemiol Community Health. 1985;39(2): Sotaniemi EA, Sutinen S, Arranto AJ, et al. Liver damage in Nurses handling cytostatic agents. Acta Med Scand. 1983;214(3): Cavallo D, Ursini CL, Perniconi B, et al. Evaluation of genotoxic effects induced by exposure to antineoplastic drugs in lymphocytes and exfoliated buccal cells of oncology nurses and pharmacy employees. Mutat Res. 2005;587(1-2): References (Cont.) 16. McDiarmid MA, Oliver MS, Roth TS, Rogers B, Escalante C. Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs. J Occup Environ Med. 2010;52(10): Connor TH, DeBord DG, Pretty JR, et al. Evaluation of antineoplastic drug exposure of health care workers at three university-based US cancer centers. J Occup Environ Med. 2010;52(10): Crauste-Manciet S, Sessink PJ, Ferrari S, Jomier JY, Brossard D. Environmental contamination with cytotoxic drugs in healthcare using positive air pressure isolators. Ann Occup Hyg. 2005;49(7): Epub 2005 Aug Power LA, Polovich M. Safe Handling Of Hazardous Drugs: Reviewing Standards for Worker Protection. Pharm Pract News. 2011; Hedmer M, Jonsson BAG, Nygren O. Development and validation of methods for environmental monitoring of cyclophosphamide in workplaces. J Environ Monit. 2004;6(12): Connor TH, Shults M, Fraser MP. Determination of the vaporization of solutions of mutagenic antineoplastic agents at 23 and 37 C using a desiccator technique. Mutat. Res. 2000; 470(1): Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. National Institute for Occupational Safety and Health. DHHS (NIOSH) Publication No ; Wick C, Slawson MH, Jorgenson JA, Tyler LS. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health Syst Pharm. 2003;60(22): Nyman HA, Jorgenson JA, Slawson MH. Workplace contamination with antineoplastic agents in a new cancer hospital using a closed-system drug transfer device. Hospital Pharmacy. 2007;42(3): Sessink P, Connor T, Jorgenson J, Tyler T. Reduction in surface contamination with antineoplastic drugs in 22 hospital pharmacies in the US following implementation of a closed system transfer device. J Oncol Pharm Pract. 2011;17(1): Harrison BR, Peters BG, Bing MR. Comparison of surface contamination with cyclophosphamide and fluorouracil using a closed-system drug transfer device versus standard preparation techniques. Am J Health Syst Pharm. 2006;63(18): Jorgenson JA, Spivey SM, et al. Contamination comparison of transfer devices intended for handling hazardous drugs. Hosp Pharm. 2008;43(9): Jorgenson JA, Spivey SM, et al. Op cit. 29. Jorgenson JA. Leakproof connection integrity test for devices intended for handling hazardous drugs. Presented at ASHP Midyear Clinical Meeting, December USP <797> Pharmaceutical Compounding Sterile Preparations. Revision Bulletin ASHP Reports: ASHP Guidelines on Handling Hazardous Drugs. Am J Health Syst Pharm. 2006;63: Polovich, M. Safe Handling of Hazardous Drugs. Pittsburgh, PA: Oncology Nursing Society;2011:34, Washington State legislation: Handling of hazardous drugs. Senate Bill BD, BD Logo, BD PhaSeal and all other trademarks are property of Becton, Dickinson and Company BD. MSS