Chapter 15: Compounding 1: Basics Flashcards
What is compounding?
Compounding is the process of altering/creating ingredients to create a new, unique prescription/medication. Compounded products are not FDA approved and are not commercially available. They are made for patients with unique needs.
What are the types of compounding?
- Sterile
- Non-Sterile
- Furthermore, these two can be further categorized into
- Hazardous
- Non-Hazardous
- Furthermore, these two can be further categorized into
Who sets the standards for compounding?
U.S. Pharmacopeia
What are the different chapters of the U.S. Pharmacopeia?
795: Non-Sterile Compounding
797: Sterile Compounding
800: Handling Hazardous Drugs
- Note that chapter 800 does not mention what drugs are hazardous, it only mentions how to handle them.
Who has declared the USP chapters as minimum acceptable standards?
- FDA
- State Board of Pharmacy
- Joint Commission
What standards do hospital pharmacists rely on for following USP Standards?
American Society of Health system Pharmacists (ASHP)
What is non-sterile compounding used for?
- To create a liquid version of a solid tablet so that a child can swallow it.
- To create a 10% ointment when only 5% and 15% are commercially available.
- To avoid an excipient (Gluten or Dye)
- To add a flavor so that a child can tolerate tasting it.
What are the routes of non-sterile preparations?
- Oral
- Tube
- Rectally
- Vaginally
- Topically
- In the ear (Otic)
Non-Sterile Compounding is divided into 3 categories depending on their complexity. What are they?
- Simple: Requires simple/minimal instructions
- Moderate: Requires specialized instructions and procedures (Mixing two creams together)
- Complex: Requires very specialized equipment, instructions, procedures, and maybe even facilities (Ex: Transdermal dosages)
What are the physical space requirements for non-sterile compounding?
There has to be a designated non-sterile compounding area that is completely away from dispensing pharmacy and sterile-compounding location. Non-sterile compounding can be conducted using typical room air. There needs to be two types of water: normal and purified (distilled). All equipment must be clean, well organized, and have space from each other. Single use towels are preferred for cleaning.
What is the ISO air quality of the SEC?
7
What is the ISO air quality of the PEC?
5
In Non-Sterile compounding, what kind of air pressure should there be?
Positive. It’s ok for air to get exposed outside of the PEC because we are dealing with non-toxic materials.
What is used to clean a PEC?
Germicidal agent
What is used to disinfect a PEC?
70% Isopropyl Alcohol
If a power outage occurs, what must be done with the PEC?
It must be cleaned, sanitized, and be left on for 30 minutes before starting to compound again.
How often is a PEC cleaned?
It is cleaned continuously throughout the day and then cleaned one last time before cleaning the SEC and the anteroom.
What is used to clean the SEC?
Lint free sterile wipes
Should you every spray anything inside of the PEC?
No
What kind of strokes should you use when cleaning the PEC?
Unidirectional strokes, never use circular motions. Use a new side of the wipe for the next area cleaned. Replace used wipes often.
What is the correct order for cleaning a horizontal laminar airflow PEC?
- Ceiling: Back to front
- The grill covering the HEPA filter: Top to bottom
- The sides: Top to bottom
- Whatever equipment or instrument is inside
- The bottom: Back to front
- Make sure to let everything dry before compounding. This should be about 30 minutes after wiping everything down.
What is the correct order and materials used for sanitization of hazardous materials?
- Deactivation and decontamination: 2% bleach or peroxide
- Cleaning: Germicidal agent such as quat, ammonium, or phenolics
- Disinfection: Sterile 70% isopropyl alcohol
What is surface sampling?
This is when surfaces in the PEC, SEC, or the anteroom are observed for any microbial growth. this must be done at least every 6 months. If microbial growth is discovered, the individual responsible must take the actions necessary to find the source of it and put an end to it.
What are the steps to take when someone is exposed to a drug?
- Remove the garb or clothing that the drug landed on.
- Wash off any drug found on skin with soap and water.
- If eyes were exposed to drug, use a eye water fountain.
- Call for medical attention if needed.
- Document the incident in the employee’s record.
