APPENDIX B

 ABBREVIATIONS AND GLOSSARY

 Abbreviations

Glossary

Antineoplastic drug: A chemotherapeutic agent that controls or kills cancer cells. Drugs used in the treatment of cancer are cytotoxic but are generally more damaging to dividing cells than to resting cells.

Aseptic: Free of living pathogenic organisms or infected materials.

Barrier system: An open system that can exchange unfiltered air and contaminants with the surrounding environment.

Barrier isolator: This term has various interpretations, especially as they pertain to hazard containment and aseptic processing. For this reason, it has been omitted from this Alert.

Biohazard: An infectious agent or hazardous biological material that presents a risk to the health of humans or the environment. Biohazards include tissue, blood or body fluids, and materials such as needles or other equipment contaminated with these infectious agents or hazardous biological materials.

Biomarker: A biological, biochemical or structural change that serves as an indicator of potential damage to cellular components, whole cells, tissues, or organs.

BSC (biological safety cabinet): A BSC may be one of several types, as described here [CDC/NIH 1999; NSF/ANSI 2002]: Class I BSC: A BSC that protects personnel and the work environment but does not protect the product. It is a Hazardous Drugs in Health Care Settings 43 negative-pressure, ventilated cabinet usually operated with an open front and a minimum face velocity at the work opening of at least 75 ft/min. A Class I BSC is similar in design to chemical fume hood except all of the air from the cabinet is exhausted through a HEPA filter (either into the laboratory or to the outside).

Class II BSC: A ventilated BSC that protects personnel, product, and the work environment. A Class II BSC has an open front with inward airflow for personnel protection, downward HEPA-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection.

Type A1 (formerly, Type A): These Class II BSCs maintain a minimum inflow velocity of 75 ft/min, have HEPAfiltered downflow air that is a portion of the mixed downflow and inflow air from a common plenum, may exhaust HEPA-filtered air back into the laboratory or to the environment through an exhaust canopy, and may have positive- pressure contaminated ducts and plenums that are not surrounded by negative- pressure plenums. They are not suitable for use with volatile toxic chemicals and volatile radionucleotides.

Type A2 (formerly, Type B3): These Class II BSCs maintain a minimum inflow velocity of 100 ft/min, have HEPA-filtered downflow air that is a portion of the mixed downflow and inflow air from a common exhaust plenum, may exhaust HEPA-filtered air back into the laboratory or to the environment through an exhaust canopy, and have all contaminated ducts and plenums under negative pressure or surrounded by negative pressure ducts and plenums. If these cabinets are used for minute quantities of volatile toxic chemicals and trace amounts of radionucleotides, they must be exhausted through properly functioning exhaust canopies.

Type B1: These Class II BSCs maintain a minimum inflow velocity of 100 ft/min, have HEPA-filtered downflow air composed largely of uncontaminated, recirculated inflow air, exhaust most of the contaminated downflow air through a dedicated duct exhausted to the atmosphere after passing it through a HEPA filter, and have all contaminated ducts and plenums under negative pressure or surrounded by negative-pressure ducts and plenums. If these cabinets are used for work involving minute quantities of volatile toxic chemicals and trace amounts of radionucleotides, the work must be done in the directly exhausted portion of the cabinet.

Type B2 (total exhaust): These Class II BSCs maintain a minimum inflow velocity of 100 ft/min, have HEPA-filtered downflow air drawn from the laboratory or the outside, exhaust all inflow and downflow air to the atmosphere after filtration through a HEPA filter without recirculation inside the cabinet or return to the laboratory, and have all contaminated ducts and plenums under negative pressure or surrounded by directly exhausted negative-pressure ducts and plenums. These cabinets may be used with volatile toxic chemicals and radionucleotides. 44 Hazardous Drugs in Health Care Settings

Class III BSC: A BSC with a totally enclosed, ventilated cabinet of gas-tight construction in which operations are conducted through attached rubber gloves and observed through a nonopening view window. This BSC is maintained under negative pressure of at least 0.50 inch of water gauge, and air is drawn into the cabinet through HEPA filters. The exhaust air is treated by double HEPA filtration or single HEPA filtration/incineration. Passage of materials in and out of the cabinet is generally performed through a dunk tank (accessible through the cabinet floor) or a double-door pass-through box (such as an autoclave) that can be decontaminated between uses. For a more detailed description, refer to CDC/NIH [2000], Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, 2nd edition. [www.cdc.gov/od/ohs/biosfty/bsc/bsc.htm].

Chemotherapy drug: A chemical agent used to treat diseases. The term usually refers to a drug used to treat cancer.

Chemotherapy glove: A medical glove that has been approved by the FDA for use when handling antineoplastic drugs.

Chemotherapy waste: Discarded items such as gowns, gloves, masks, IV tubing, empty bags, empty drug vials, needles and syringes, and other items generated while preparing and administering antineoplastic agents.

Closed system: A device that does not exchange unfiltered air or contaminants with the adjacent environment.

Closed system drug-transfer device: A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.

Cytotoxic: A pharmacologic compound that is detrimental or destructive to cells within the body.

Deactivation: Treating a chemical agent (such as a hazardous drug) with another chemical, heat, ultraviolet light, or other agent to create a less hazardous agent.

Decontamination: Inactivation, neutralization, or removal of toxic agents, usually by chemical means.

Engineering controls: Devices designed to eliminate or reduce worker exposures to chemical, biological, radiological, ergonomic, or physical hazards. Examples include laboratory fume hoods, glove bags, retracting syringe needles, sound-dampening materials to reduce noise levels, safety interlocks, and radiation shielding.

Genotoxic: Capable of damaging the DNA and leading to mutations.

Glove box: A controlled environment work enclosure providing a primary barrier from the work area. Operations are performed through sealed gloved openings to protect the worker, the ambient environment, and/ or the product.

Glove bag: A glove box made from a flexible plastic film. Operations are performed through sealed gloved openings to protect the worker, the work environment, and/or the product.

Hazardous drug: Any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.

Hazardous waste: Any waste that is a RCRA-listed hazardous waste [40 CFR 261.30– 33] or that meets a RCRA characteristic of ignitability, corrosivity, reactivity, or toxicity as defined in 40 CFR 261.21–24.

Health care settings: All hospitals, medical clinics, outpatient facilities, physicians’ offices, retail pharmacies, and similar facilities dedicated to the care of patients.

Health care worker: All workers who are involved in the care of patients. These include pharmacists, pharmacy technicians, nurses (registered nurses [RNs], licensed practical nurses [LPNs], nurses aids, etc.), physicians, home health care workers and environmental services workers (housekeeping, laundry, and waste disposal).

HEPA filter: High-efficiency particulate air filter rated 99.97% efficient in capturing 0.3-micron-diameter particles.

Horizontal laminar flow hood (horizontal laminar flow clean bench): A device that protects the work product and the work area by supplying HEPA-filtered air to the rear of the cabinet and producing a horizontal flow across the work area and out toward the worker.

Isolator: A device that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and may be reproducibly decontaminated. When closed, an isolator uses only decontaminated interfaces (when necessary) or rapid transfer ports (RTPs) for materials transfer. When open, it allows for the ingress and/or egress of materials through defined openings that have been designed and validated to preclude the transfer of contaminants or unfiltered air to adjacent environments. An isolator can be used for aseptic processing, for containment of potent compounds, or for simultaneous asepsis and containment. Some isolator designs allow operations within the isolator to be conducted through attached rubber gloves without compromising asepsis and/or containment.

Aseptic isolator: A ventilated isolator designed to exclude external contamination from entering the critical zone inside the isolator.

Aseptic containment isolator: A ventilated isolator designed to meet the requirements of both an aseptic isolator and a containment isolator.

Containment isolator: A ventilated isolator designed to prevent the toxic materials processed inside it from escaping to the surrounding environment.

Lab coat: A disposable or reusable open front coat, usually made of cloth or other permeable material.

MSDS: Material safety data sheet. These sheets contain summaries provided by the manufacturer to describe the chemical properties and hazards of specific chemicals and ways in which workers can protect themselves from exposure to these chemicals.

Mutagenic: Capable of increasing the spontaneous mutation rate by causing changes in the DNA.

OEL: Occupational exposure limit. An industry or other non-government exposure limit usually based on scientific calculations of airborne concentrations of a substance that are considered to be acceptable for healthy workers.

PDA: An international trade association serving pharmaceutical science and technology. Formerly knownas the Parenteral Drug Association.

PEL: OSHA permissible exposure limit: The time-weighted average concentration of a substance to which nearly all workers may be exposed for up to 8 hours per day, 40 hours per week for 30 years without adverse effects. A PEL may also include a skin designation.

PPE: Personal protective equipment. Items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.

REL: NIOSH recommended exposure limit: An occupational exposure limit recommended by NIOSH as being protective of worker health and safety over a working lifetime. The REL is frequently expressed as a time weighted average exposure to a substance for up to a 10-hour workday during a 40-hour work week.

Respirator: A type of PPE that prevents harmful materials from entering the respiratory system, usually by filtering hazardous agents from workplace air. A surgical mask does not offer respiratory protection.

Risk assessment: Characterization of potentially adverse health effects from human exposure to environmental or occupational hazards. Risk assessment can be divided into five major steps: hazard identification, dose-response assessment, exposure assessment, risk characterization, and risk communication.

Sister chromatid exchange: The exchange of segments of DNA between sister chromatids.

Standard precautions (formerly universal precautions): The practice in health care of treating all patients as if they were infected with HIV or other similar diseases by using barriers to avoid known means of transmitting infectious agents [CDC 1987, 1988]. These barriers can include nonporous gloves, goggles, and face shields. Careful handling and disposal of sharps or the use of needleless systems are also important.

TLVs®: Threshold limit values. These values are exposure limits established by the ACGIH. They refer to airborne concentrations of chemical substances and represent conditions under which it is believed that nearly all workers may be repeatedly exposed, day after day, over a working lifetime, without adverse health effects.

Ventilated cabinet: A type of engineering control designed for purposes of worker protection (as used in this document). These devices are designed to minimize worker exposures by controlling emissions of airborne contaminants through the following:

 The full or partial enclosure of a potential contaminant source

 The use of airflow capture velocities to capture and remove airborne contaminants near their point of generation

 The use of air pressure relationships that define the direction of airflow into the cabinet

Examples of ventilated cabinets include BSCs, containment isolators, and laboratory fume hoods.

WEEL (workplace environmental exposure level): Occupational exposure limits developed by the American Industrial Hygiene Association as a chemical concentration to which nearly all workers may be repeatedly exposed for a working lifetime without adverse health effects.

 APPENDIX C

 NIOSH HAZARDOUS DRUG SAFETY WORKING GROUP

The following members of the NIOSH Hazardous Drug Safety Working Group provided leadership, information, and recommendations for this document:

ACKNOWLEDGMENTS

This Alert was written by G. Edward Burroughs, Ph.D., C.I.H.1; Thomas H. Connor, Ph.D.1; Melissa A. McDiarmid, M.D., M.P.H.4; Kenneth R. Mead, M.S., P.E.1; Luci A. Power, M.S., R.Ph.6; and Laurence D. Reed, M.S.1

Major contributors to this Alert were Barbara J. Coyle, B.S.N., R.N. C.O.H.N.-S.2; Duane R. Hammond, B.S.M.E.1; Melissa M. Leone, R.N., B.S.N.3; Marty Polovich, M.N., R.N., A.O.C.N.5; and Douglas D. Sharpnack, D.V.M.1

Contributions to this Alert were also made by members of the NIOSH Hazardous Drug Safe Handling Working Group. A complete listing of the agencies and organizations who contributed to this Alert is listed in Appendix C. Anne C. Hamilton, Vanessa Becks, Susan Afanuh, Jane Weber, Andre Allen, Anne Votaw, and Teresa Lewis provided editorial and production services.

1NIOSH; 2State of Wisconsin; 3Apria Healthcare; 4University of Maryland; 5Oncology Nursing Society; 6University of California Medical Center

20 Hazardous Drugs in Health Care Settings Support for the development of this Alert was provided by the National Occupational Research Agenda (NORA) Control Technology and Personal Protective Equipment Team and the NORA Reproductive Health Research Team.

Please direct comments, questions, or requests for additional information to the following:

Director, Division of Applied Research and Technology

National Institute for Occupational Safety and Health

4676 Columbia Parkway

Cincinnati, OH 45226–1998

Telephone: 1–513–533–8462 or

1–800–35–NIOSH

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