Compounding I: Basics Flashcards
What sets the standards for compounding preparations?
US Pharmacopia (USP)
What are the USP 795, 797, and 800 chapters on?
795 – Non-sterile compounding
797 – Sterile compounding
800 – Hazardous drugs
What does the National Institute for Occupational Safety and Health (NIOSH) determine?
Which drugs are hazardous
What is the NIOSH list of hazardous drugs called?
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings
What are safety data sheets (SDS)?
Series of safety documents required by the occupational safety and health administration (OSHA) to be accessible to all employees who are working with hazardous materials
True or false – the dose and formulation of a compounded medication can NOT be commercially available for a pharmacist to compound it
True – if it can be bought, then buy it
What is non-sterile compounding primarily used for?
Change formulation (from tablet to liquid) Avoid an excipient Prepare a dose or formulation that is not commercially available Add a flavor
Sterile products that are injected into the blood must be free of what?
Microorganisms and other contaminants
Sterile compounding is primarily used to prepare what?
Non hazardous sterile IV drugs Hazardous sterile IV drugs Radiopharmaceuticals Eyedrops Irrigations
What characteristics make a drug hazardous?
Carcinogenic
Teratogenic
Causes organ toxicity
Genotoxic (damages DNA)
What type of air pressure is required in a room where hazardous drugs are being compounded?
Negative
Where to store hazardous drugs?
Away from non-hazardous drugs
In a room where hazardous drugs are compounded, how many air changes per hour (ACPH) are needed?
Non sterile HD: 12 or more
Sterile HD: 30 or more
What medications are antineoplastic
chemo drugs
What does primary engineering control (PEC) mean?
Sterile hood
What does secondary engineering control (SEC) mean?
Buffer room
What is the compounding aseptic isolator (CAI)?
A hood that is completely closed in and has gloves and sleeves to put your hands in
What is considered a small volume parenteral? Large volume parenteral?
Small: 100 ml or less
Large: over 100 ml
What is the ISO rating and number of particles allowed for the following area
Primary engineering control (sterile hood, isolator, glove box)
ISO - 5
Particles/m3 - 3520
What is the ISO rating and number of particles allowed for the following area
Non pharmacy spaces
ISO - 6
Particles/m3 - 35,200
What is the ISO rating and number of particles allowed for the following area
Secondary engineering control (buffer room, anteroom if it opens into a negative pressure buffer room)
ISO - 7
Particles/m3 - 352,000
What is the ISO rating and number of particles allowed for the following area
Anteroom if it opens into a positive pressure buffer room
ISO - 8
Particles/m3 - 3,520,000
What does HEPA filter stand for? How efficient are they at removing particles 0.3 microns or larger?
High-efficiency particulate air
>99.97% efficient
Does air flow vertically or horizontally in a laminar airflow workbench?
verticle (Up)
How often does a HEPA filter need to be recertified by a specialist?
Every 6 months
What type of air has an ISO rating of 9?
Room air
What does the line of demarcation separate?
Clean and dirty sections of the anteroom
How long is the beyond use date for something that was prepared in non-sterile conditions (for code, emergency, etc)
1 hour
If a clean room is being used to compound hazardous drugs, should it have positive or negative pressure?
Negative (keeps all hazardous particles in the room)
What types of hoods can be used in non-HD and HD cleanrooms?
non-HD: Compounding aseptic isolator (CAI) and laminar airflow workbench (LAFW)
HD: Compounding aseptic containment isolator (CACI) and biological safety cabinet (BSC)
What is a segregated compounding area (SCA)? When is it used? BUD for medications made here
Option when cleanroom is not available
Does not have buffer area or anteroom
Usually in satellite pharmacies
Max BUD is 12 hours
True or false:
Closed front hoods do not need to be placed inside an SEC
True b/c they are closed off to outside air
Includes Compounding aseptic isolator (CAI) and compounding aseptic containment isolator (CAIC) (both are “glove boxes”
Which closed front PECs are used for hazardous materials? non hazardous?
Hazardous: Compounding aseptic CONTAINMENT isolator (CAIC) - contains hazardous drugs
Non-hazardous: Compounding aseptic isolator (CAI)
How often is a fingertip test required?
Initially (when training for the first time) then annually if compounding low and medium-risk CSPs and semi annually if compounding high-risk CSPs
How long must the liquid in a media fill test bag stay clear for a person to pass?
14 days
How often does temp need to be monitored in the SEC? What should it be?
Daily
20C (68F) or cooler
How often should the refrigerator and freezer be monitored? What if it contains vaccines?
Daily
twice daily if contains vaccines
How often should the air, surfaces, air pressure, and humidity be tested in the compounding area of a pharmacy?
Air: Every 6 months
Surfaces: periodically
Air pressure: each shift (preferably) or daily (minimally)
Humidity: daily
What should be done in a sterile compounding room if the power goes out?
Stop compounding (air isn't being removed, filtered, etc) Clean with germicidal detergent then disinfected with sterile 70% isopropyl alcohol (IPA)
How to clean an area that was used to compound a hazardous drug?
Deactivate and decontaminate (bleach or peroxide)
Cleaning (germicidal detergent)
Disinfection (isopropyl alcohol)
When compounding hazardous drugs, what do the black, yellow, and red bins contain?
Black: Bulk hazardous waste
Yellow: trace hazardous waste (including HD sharps)
Red: sharps - NOT FOR HAZARDOUS WASTE
What must be done every time there is a HD spill in the hood?
Decontamination with bleach or peroxide
When a HD is unpacked and it is not contained in plastic, what should the HCP wear?
Elastomeric half-mask with a multi-gas cartridge and P100-filter
What does an N95 mask not protect against?
Gasses
Where should you look for information on how to clean up a HD spill?
Safety data sheet (SDS)
Can you use a pneumatic tube to transport HD?
Cannot be used for any liquid or antineoplastic (cancer) drugs
When are double ASTM D6978 gloves required?
When cleaning up HD spills
Order for garbing up
Head and facial covers Shoe covers Wash hands Gown Gloves Sanitize gloves with alcohol regularly
What is required when garbing up for compounding HD that is not required for non-HD drugs?
Respirator Face mask Head AND hair coverings Eye/face protection Chemo gown Chemo gloves Two pairs of shoe covers
