630 Healthcare: Pharmacy Safety

Glossary

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A

• Administrative Controls. Work policies and schedules implemented to reduce risk of exposure, such as limiting the time a pharmacy technician spends in hazardous drug areas, or instituting double-check systems for controlled substance dispensing.
• Ante Room. A transition space between the general pharmacy and cleanroom (buffer area) used for hand hygiene, garbing, and staging of supplies. Required in sterile compounding environments under USP <797>.

B

• Beyond-Use Date (BUD). The date or time after which a compounded sterile preparation (CSP) should not be used, based on the date/time of compounding and storage conditions. BUDs are determined by USP <797> to ensure patient safety and drug efficacy.
• Baseline Survey. An initial assessment conducted to determine existing conditions in a workplace, such as exposure levels, ergonomic risks, or compliance with safety standards. It provides a reference point for future improvements and interventions.
• Buffer Area. The primary cleanroom space where sterile compounding occurs. Classified as ISO Class 7 or better under USP <797>, it must be physically separated and maintained under positive pressure (unless compounding hazardous drugs).

C

• Cleaning and Disinfection. Procedures required by USP <797> and <800> to ensure aseptic conditions and prevent contamination. Includes the use of sporicidal agents, alcohol, and disinfectants applied on a defined schedule.
• Closed System Transfer Device (CSTD). A drug transfer device that mechanically prevents the transfer of environmental contaminants into the system and the escape of hazardous drug vapors or liquids out. CSTDs are used in pharmacies to protect workers during the preparation and administration of hazardous drugs.
• Competent Person. An individual who is capable of identifying existing and predictable hazards in the surroundings or working conditions and who has the authority to take prompt corrective actions to eliminate them. Often used in OSHA contexts, including health and safety assessments.
• Compounded Nonsterile Preparation (CNSP). Any medication that is compounded without the requirement for sterility. USP <795> provides guidelines for compounding, labeling, and storage of CNSPs.
• Compounded Sterile Preparation (CSP). A medication compounded under sterile conditions, such as injections or eye drops. USP <797> sets the standards for preparing CSPs safely and effectively.
• Compounding Aseptic Containment Isolator (CACI). A ventilated cabinet used in pharmacies for preparing hazardous drugs in a sterile environment, providing protection to both the worker and the product. Required by USP <800> for certain hazardous drug compounding.
• Containment Primary Engineering Control (C-PEC). A ventilated device such as a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) used for the sterile or nonsterile compounding of hazardous drugs under USP <800>.
• Containment Secondary Engineering Control (C-SEC). The room in which the C-PEC is located. Under USP <800>, it must meet specific requirements including negative pressure, air changes per hour (ACPH), and ISO classification if compounding sterile hazardous drugs.
• Containment Segregated Compounding Area (C-SCA). A designated space for compounding hazardous sterile drugs when full ISO Class 7 buffer and ante rooms are not used. C-SCAs are permitted under USP <800> with strict controls on airflow and beyond-use dates.

D

• Decontamination. In pharmacy practice, decontamination refers to removing hazardous drug residues from surfaces, workstations, and equipment in sterile compounding rooms using agents like sodium hypochlorite and sodium thiosulfate.
• Dispensing Errors. Mistakes in the preparation, labeling, or distribution of medications, which may include incorrect drug, dose, or patient. Pharmacy safety protocols and barcode verification systems help prevent these errors.
• Donning and Doffing. The procedures for putting on (donning) and removing (doffing) personal protective equipment (PPE). USP <797> and <800> require specific steps and orders for garbing to maintain sterile conditions and protect personnel from exposure.

E

• Engineering Controls. In pharmacies, these include devices and systems like laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), CSTDs, and negative pressure rooms that physically prevent or minimize hazardous drug exposure.
• Ergonomics. In the pharmacy, this refers to organizing the physical layout to reduce strain from repetitive tasks like pill counting, inventory stocking, and typing. Proper ergonomics prevent musculoskeletal disorders among pharmacists and technicians.

F

• Fume Hood. A ventilated enclosure in laboratories and pharmacies designed to limit exposure to hazardous or toxic fumes, vapors, or dust. Used especially when compounding or mixing volatile substances.

G

• Gowning. The process of donning protective garments such as sterile gowns, gloves, masks, and shoe covers before entering cleanrooms or compounding areas to prevent contamination. Critical for compliance with USP <797> and <800>.

H

• Hazard Communication Program. In a pharmacy setting, this includes ensuring that Safety Data Sheets (SDSs) are accessible for all chemicals used, including alcohols, cleaning agents, and hazardous drugs, and that staff are trained in interpreting labels and hazard symbols.
• Hazardous Drugs. Drugs handled in pharmacies that pose significant occupational risks to staff. These include chemotherapy agents, hormone therapies, and antiviral medications. NIOSH and USP <800> guidelines require special handling, PPE, and facilities for these drugs.
• Hazardous Waste. Waste materials that pose substantial or potential threats to public health or the environment. In pharmacies, includes expired chemotherapy drugs, contaminated PPE, and certain solvents or chemicals. Must be disposed of in accordance with EPA and RCRA regulations.
• Hierarchy of Hazard Controls. Pharmacy safety follows this hierarchy: eliminating unnecessary use of hazardous drugs, substituting with less harmful compounds, using engineering controls (e.g., BSCs), establishing administrative policies (e.g., spill response), and equipping staff with PPE.
• HIPAA. In pharmacies, HIPAA ensures that patient prescriptions, medication records, and counseling sessions remain confidential. Pharmacy staff must be trained in HIPAA compliance and secure handling of electronic and printed records.

I

• Inspections. Regular evaluations by pharmacy managers, regulatory agencies, or third-party auditors to ensure compliance with USP <795>, <797>, <800>, OSHA, and state board regulations. Inspections often review recordkeeping, cleanroom practices, and staff training logs.

J

• Joint Commission. A nonprofit organization that accredits and certifies healthcare organizations in the U.S. Its standards emphasize patient safety, infection control, and proper medication management, including in pharmacies.

K

• Kill Time. The amount of time a disinfectant must remain on a surface to effectively kill pathogens. Pharmacy staff must adhere to proper kill times during cleaning to maintain sterile conditions in compounding areas.

L

• Laminar Airflow Workbench (LAFW). A workspace that directs HEPA-filtered air in a unidirectional flow to maintain a sterile environment for preparing medications. Often used for non-hazardous sterile compounding under USP <797>.

M

• Master Formulation Record (MFR). A detailed, written procedure for compounding a specific preparation. Required by USP <795> to ensure consistency, accuracy, and traceability in nonsterile compounding.
• Material Safety Data Sheet (MSDS). Now known as Safety Data Sheet (SDS), this document provides detailed information on handling, storing, and responding to exposure from chemicals or pharmaceuticals. Required as part of OSHA's Hazard Communication Standard.

N

• Negative Pressure Room. A room with lower air pressure than adjacent areas to prevent hazardous drug vapors or particles from escaping. Required by USP <800> for hazardous drug compounding rooms to contain contaminants.
• NIOSH. Provides hazard classifications and handling recommendations for drugs in pharmacy environments. Publishes the "NIOSH List of Hazardous Drugs," a critical reference for developing pharmacy safety policies.

O

• OSHA. Regulates workplace safety for pharmacy environments, including standards for hazard communication, bloodborne pathogens, PPE, and ergonomics. Pharmacy employers are responsible for OSHA compliance and employee training.

P

• Personal Protective Equipment (PPE). In pharmacy compounding, PPE includes chemotherapy gowns, sterile gloves, shoe covers, hair covers, face shields, and respirators when handling hazardous drugs. Proper donning and doffing procedures are essential for worker protection. Under USP <800>, required PPE includes chemotherapy gloves, gowns, head and shoe covers, and respiratory protection for HD handling.
• Primary Engineering Control (PEC). A device or room that provides an ISO Class 5 environment for sterile drug preparation, such as a laminar airflow workbench (LAFW) or biological safety cabinet (BSC). Required by USP <797>.
• Proper Disposal. Includes using black bins for hazardous pharmaceutical waste, red bins for biohazardous sharps, and following Drug Enforcement Administration (DEA) protocols for controlled substances. Prevents diversion, environmental harm, and exposure.

Q

• Qualified Person. Someone who, by possession of a recognized degree, certificate, or professional standing (or extensive knowledge and experience), is capable of planning or evaluating workplace safety practices and systems. Often associated with hazardous drug programs or training assessments.
• Quality Assurance (QA) Program. A documented set of procedures ensuring that compounded preparations meet specified standards. Required under all USP compounding chapters to ensure product integrity, accuracy, and sterility or cleanliness.

R

• Routes of Entry. Relevant in pharmacy when handling powdered drugs or aerosols; includes skin absorption during spills, inhalation during compounding, ingestion from hand-to-mouth contact, and needlestick injuries during reconstitution or injections.

S

• Safe Practices. Pharmacy-specific practices include labeling all syringes and vials, avoiding touching sterile parts of equipment, maintaining appropriate garbing, performing hand hygiene before compounding, and logging refrigerator temperatures.
• Safety Equipment. Includes spill kits, eye wash stations, sharps containers, and fume hoods in the pharmacy. Regular maintenance and employee familiarity with their locations are crucial for emergency preparedness.
• Security. In pharmacies, includes preventing drug diversion, controlling access to controlled substances, implementing video surveillance, and locking narcotics storage areas. Pharmacy staff must be trained in recognizing suspicious activity.
• Segregated Compounding Area (SCA). A designated space for preparing low-risk CSPs with shorter BUDs when full cleanroom infrastructure is not available. Permitted under USP <797> with specific criteria.
• Standard Operating Procedure (SOP). A detailed, written protocol for performing a specific operation, such as cleaning, garbing, or compounding. USP <795>, <797>, and <800> require SOPs to maintain consistency and compliance.
• Surface Sampling. A process for testing work surfaces for microbial contamination or hazardous drug residue. Required at regular intervals under USP <797> (for sterility) and USP <800> (for HD residue).
• Surveys. Used in pharmacies to assess compliance with safety policies, employee understanding of hazardous drug procedures, and patient satisfaction. Often part of quality assurance and improvement efforts.

T

• Training. In pharmacies, this includes onboarding for USP <795>, <797>, and <800> compliance, hazardous drug handling, spill response, HIPAA, and OSHA topics. Regular competency assessments are required for continued certification.

U

• Universal Precautions. A set of practices intended to prevent the transmission of bloodborne pathogens by treating all human blood and body fluids as potentially infectious. Applies to pharmacists handling sharps or cleaning up spills.
• USP <795>. A United States Pharmacopeia chapter outlining best practices for nonsterile compounding, including formulation, quality control, documentation, and proper facility maintenance.
• USP <797>. A USP chapter detailing standards for sterile compounding to ensure patient safety, including cleanroom design, environmental monitoring, and sterile technique.
• USP <800>. A USP chapter focused on the safe handling of hazardous drugs to minimize exposure to healthcare workers, patients, and the environment. Includes rules for storage, compounding, PPE, and disposal.

V

• Ventilated Workstation. A type of engineering control used in pharmacies for preparing hazardous drugs. These workstations maintain negative air pressure and direct airflow away from the user to reduce inhalation exposure.
• Xylene. A flammable and potentially toxic solvent sometimes used in healthcare labs. Xylene exposure can occur through inhalation or skin contact and must be handled with appropriate PPE and ventilation.
• Yellow Bin. A color-coded waste container used for chemotherapy and hazardous drug waste. Pharmacy workers are trained to discard PPE and contaminated materials into yellow bins to prevent accidental exposure or environmental contamination.
• Zone of Contamination. In pharmacy settings, this refers to areas where hazardous drugs are prepared or stored, often requiring containment strategies such as negative pressure and restricted access to prevent contamination of adjacent zones.

W

• Workplace Violence Prevention. Pharmacy settings, particularly retail, are vulnerable to robbery and aggressive customers. Prevention includes physical barriers, panic buttons, staff training, and reporting mechanisms for threats or harassment.

X

• Xylene. A flammable and potentially toxic solvent sometimes used in healthcare labs. Xylene exposure can occur through inhalation or skin contact and must be handled with appropriate PPE and ventilation.

Y

• Yellow Bin. A color-coded waste container used for chemotherapy and hazardous drug waste. Pharmacy workers are trained to discard PPE and contaminated materials into yellow bins to prevent accidental exposure or environmental contamination.

Z

• Zone of Contamination. In pharmacy settings, this refers to areas where hazardous drugs are prepared or stored, often requiring containment strategies such as negative pressure and restricted access to prevent contamination of adjacent zones.