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Studying for the Naplex > Chapter 15: Compounding 1: Basics > Flashcards

Chapter 15: Compounding 1: Basics Flashcards

1
Q

What is compounding?

A

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.

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2
Q

What are the types of compounding?

A
  1. Sterile
  2. Non-Sterile
    • Furthermore, these two can be further categorized into
      1. Hazardous
      2. Non-Hazardous
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3
Q

Who sets the standards for compounding?

A

U.S. Pharmacopeia

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4
Q

What are the different chapters of the U.S. Pharmacopeia?

A

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.

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5
Q

Who has declared the USP chapters as minimum acceptable standards?

A
  1. FDA
  2. State Board of Pharmacy
  3. Joint Commission
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6
Q

What standards do hospital pharmacists rely on for following USP Standards?

A

American Society of Health system Pharmacists (ASHP)

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7
Q

What is non-sterile compounding used for?

A
  1. To create a liquid version of a solid tablet so that a child can swallow it.
  2. To create a 10% ointment when only 5% and 15% are commercially available.
  3. To avoid an excipient (Gluten or Dye)
  4. To add a flavor so that a child can tolerate tasting it.
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8
Q

What are the routes of non-sterile preparations?

A
  1. Oral
  2. Tube
  3. Rectally
  4. Vaginally
  5. Topically
  6. In the ear (Otic)
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9
Q

Non-Sterile Compounding is divided into 3 categories depending on their complexity. What are they?

A
  1. Simple: Requires simple/minimal instructions
  2. Moderate: Requires specialized instructions and procedures (Mixing two creams together)
  3. Complex: Requires very specialized equipment, instructions, procedures, and maybe even facilities (Ex: Transdermal dosages)
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10
Q

What are the physical space requirements for non-sterile compounding?

A

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.

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11
Q

What is the ISO air quality of the SEC?

A

7

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12
Q

What is the ISO air quality of the PEC?

A

5

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13
Q

In Non-Sterile compounding, what kind of air pressure should there be?

A

Positive. It’s ok for air to get exposed outside of the PEC because we are dealing with non-toxic materials.

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14
Q

What is used to clean a PEC?

A

Germicidal agent

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15
Q

What is used to disinfect a PEC?

A

70% Isopropyl Alcohol

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16
Q

If a power outage occurs, what must be done with the PEC?

A

It must be cleaned, sanitized, and be left on for 30 minutes before starting to compound again.

17
Q

How often is a PEC cleaned?

A

It is cleaned continuously throughout the day and then cleaned one last time before cleaning the SEC and the anteroom.

18
Q

What is used to clean the SEC?

A

Lint free sterile wipes

19
Q

Should you every spray anything inside of the PEC?

A

No

20
Q

What kind of strokes should you use when cleaning the PEC?

A

Unidirectional strokes, never use circular motions. Use a new side of the wipe for the next area cleaned. Replace used wipes often.

21
Q

What is the correct order for cleaning a horizontal laminar airflow PEC?

A
  1. Ceiling: Back to front
  2. The grill covering the HEPA filter: Top to bottom
  3. The sides: Top to bottom
  4. Whatever equipment or instrument is inside
  5. The bottom: Back to front
  6. Make sure to let everything dry before compounding. This should be about 30 minutes after wiping everything down.
22
Q

What is the correct order and materials used for sanitization of hazardous materials?

A
  1. Deactivation and decontamination: 2% bleach or peroxide
  2. Cleaning: Germicidal agent such as quat, ammonium, or phenolics
  3. Disinfection: Sterile 70% isopropyl alcohol
23
Q

What is surface sampling?

A

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.

24
Q

What are the steps to take when someone is exposed to a drug?

A
  1. Remove the garb or clothing that the drug landed on.
  2. Wash off any drug found on skin with soap and water.
  3. If eyes were exposed to drug, use a eye water fountain.
  4. Call for medical attention if needed.
  5. Document the incident in the employee’s record.

Studying for the Naplex (13 decks)

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