Week 5: USP 800

USP 800

provides standards for safe handling of hazardous drugs with the goals of minimizing risk of exposure to healthcare personnel, patients, and the environemnt

exposure

opportunities for _______________________:

-receiving broken vial

-dispensing

-compounding

-administration

-patient care activities

-spills

-transport

-waste

12

room containing the storage of hazardous drugs must have at least ______ air changes per hour and be externally ventilated

negative

hazardous drugs are stored in a ____________ pressure room

engineering controls

used to protect preparation from cross-contamination and microbial contamination, as well as minimizing staff and environmental hazardous drug exposure

C-SEC

_________ requirements:

-externally vented

-physically separated from other rooms

-appropriate air exchanges (per hour)

-negative pressure of 0.01-0.03 inches of water column

C-PEC

_________ requirement: operate continuously if creating some or all of the negative pressure in the C-SEC or if used for sterile compounding

Ex: CVE, BSC, CACI

ISO standards

categorize air cleanliness in terms of particulate matter

less

the higher the ISO number, the __________ clean the room is

5

primary engineering controls (C-PEC) have air quality of ISO _____ or better and are externally vented

30

secondary engineering controls (C-SEC) in an ISO 7 buffer room must be externally vented and have _____ air changes per hour

12

secondary engineering controls (C-SEC) in an unclassified containment segregated compounding area (C-SCA) must be externally vented and have ______ air changes per hour

closed system transfer devices

contained supplemental engineering controls that offer protection while compounding; may not always work perfectly and not all hazardous drugs are compatible

6 months

environmental wipe sampling for hazardous drug on surfaces should occur as a baseline every _________________ in the interior of C-PEC and equipment within it, pass-through windows, staging areas near the C-PEC, areas near the C-PEC such as the floor, areas immediately outside the buffer room/C-SCA, and patient administration areas

PPE

must be used whenever handling hazardous drugs; institutions have standard operating procedures

donning

putting on PPE

doffing

removing PPE - all PPe worn while compounding should be treated as if it may have hazardous drug on it

damage

products should be inspected for signs of ______________ before being opened

packing

_____________ should be durable enough to protect the product as well as contain any drug if it would leak during transport; often zip-lock style bags are used

administration

safe __________________ includes:

-using closed system transfer devices

-wearing appropriate PPE

-avoid exposure

deactivation

the process of inactivating the hazardous drug

ex: peroxide formulations, sodium hypochlorite

decontamination

the removal of hazardous drug residue

Ex: alcohol, water, peroxide, sodium hypochlorite

cleaning

the removal of organic and inorganic materials

Ex: germicidal agents

disinfection

the destruction of microorganisms

Ex: disinfectants, sterile alcohol

spills

all staff who may be around a ___________ need management and use of PPE and NIOSH respirator training;

medical surveillance

helps to assess for changes over time in employee health through labs and health condidions

exposure history

assessment of ______________________: quantifying how many doses/how much time an employee was in contact with hazardous drugs

ACT (actual body weight)

a patient's measured body weight

IBW (ideal body weight)

calculated based on a person's hight

ABW (adjusted body weight)

usually used for patients who are overweight or obese with the intent of minimizing "over-dosing" and prevent toxicities

BSA (body surface area)

50 kg + 2.3 kg for each inch over 5 feet

formula for male IBW

45.5 kg + 2.3 kg for each inch over 5 feet

formula for female IBW

IBW + 0.4(ACT - IBW)

formula for ABW

2.54

number of centimeters in an inch

2.2

number of pounds in a kilogram