Week 2 Flashcards
Components of Immediate use CSPs
- Compounding in normal air(patient bedside)
- Aseptic technique, processes and procedures followed
- Personnel are trained and demonstrate competency
- Cannot invlove more than three different sterile products(two or more of the same product may be used)
- Any unused starting component from single dose container must be discarded
What are the categories of CSPs?
- Immediate Use CSPs
- Categoy 1
- Category 2
- Category 3
How long after preparation should products made via Immediate use CSPs be used ?
Within 4 hours
Categorization based on microbial contamination risk levels
- Low risk—-> Category 1
- Medium risk—-> Category 2
- High-risk—–> Category 3
Component of Category 1 CSPs
Prepared in an ISO Class 5 or better primary engineering control(PEC) that maybe placed in an unclassified segregated compounding area and have shorter BUDS
Outside of the cleanroom
Category 2 CSPs
Prepared in a cleanroom suite and have longer BUDs
Category 3 CSPs
Undergo sterility testing, supplemented by endotoxin testing when applicable, and have more requirments than Category 2
Needs personal qualification
Use of sterile garb
Use of sporicidals
Frequent environmental monitoring
Stability determination
What are storage conditions?
- Controlled room temp (CRT)—> 20-25 celcius
- Refrigerattor—> 2-8 celcius
3.Freezer—>-25 to -10 celcius
Beyond Use dates(BUDs)
Assigned based on categories AND additional prep characterisitics and storage conditions
T/F: If a compound is only stable for 12 hours, the BUD can be assigned as 9 days
False: the BUD can not be longer than the stabilty of the product
BUD is always the shorter of the stability of the mixture or the allowed BUD times
Category 1 CSP: BUD
Segregated Compounding area: <12 hours at CRT ; </24 hours in refrigerator
Catgory 2 CSP: BUD
Aseptically processed, no sterility testing, only sterile starting components
* 4 days at CRT
* 10 days in refrigerator
* 45 days in freezer
Category 3 CSP: BUD
Aspetically processed, sterility tested and passing all applicable tests for category 3
* 60 days at CRT
* 90 days in refrigerator
* 120 days in freezer
Longer BUDS with colder temps; sterility /release testing ;improved environmental controls
BUDs of stock solutions
In use stock solutions —–> 12 hour max BUD
When is IV adminsitration required?
- Patient is NPO
- Drug with poor oral bioavailability
- Faster onset of action
Venous catheter
Catheter(piece of plastic tubing) inserted into a vein, used for fluid or drug delivery
Can be central or peripheral
Peripheral Venous Catheter
- Peripheral line
- Small IV catheter placed into smaller peripheral vein for short term use—> medications, fluids, TPN, blood draws
Central Venous Catheter(CVC)
- Central line
- IV catheter terminating at superior vena cava(large vein) where contents are quickly diluted
- Peripherally inserted central catheter(PICC)
- Tunneled-CVC
- Mediport
Advantages and disadvantages of Peripheral catheters
- Convenient, easy-to-place
- Minimal adverse effects when placed
- Limitations on what can be infused
- Short term use (hours/days)
Advantages and Disadvantages of central catheter
- Placement requires trained personnel, may require sedation
- Complications (infections, line-related)
- Fewer limitations on what can be infused; can infuse higher volumes at faster rates
- Long term(weeks/months/years)
Characterization of Phlebitis
- Tenderness
- Redness
- Puffiness
- Increased temp
Extravasation
an infiltration of a vesicant into the surrounding tissue
What is a vessicant?
Drug that can result in tissue necrosis when accidentally infused into the tissue surrounding a vein
Examples of vessicants
- Vassopressors(dopamine,epinephrine, norepinephrine)
- Chemotherapeutic agents(doxorubicin,vincritine,vinblastine)
- calcium salts
- digoxin
- promethazine
- naficillin
