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Lab exam
lab exam
176
Pharmacology
Graduate
10/05/2011

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Cards

Term
(t/f) A compounded products primay and auxiliary labels serve as communication tools regarding proper handling, storage, administration and drug information for the person administering the drug
Definition
True
Term
(t/f)It is preferred to label a compounded product with brand and trade name of the active drug
Definition
False
Term
(t/f)If labels on compounded products become unattached while stored in a nursing station refigerator, it is acceptable for the unit clerk to re-label the products
Definition
False
Term
(t/f) It is inappropriate to label a syringe with the appropriate administration route, as the MD may change the route before the dose is due
Definition
False
Term
For a 6mo old baby receiving routine vaccinations which is the preferred muscle for an IM injection?
Definition
vastus lateralis
Term
For a 6mo old baby receiving an IM injection what would be the max volume aloud for each IM injection?
Definition
1ml
Term
For a syringe that is filled with a dose, but does not contain a needle, what additional volume of drug should be added to the syringe to "prime" the needle that will be attached at the time of administration?
Definition
0.1ml
Term
What two pieces of information must be considered when assigning a BUD on a compounded sterile products label?
Definition
Stability
Sterility
Term
What are the two primary differences between a label used in an institutional setting and an in-home care setting?
Definition
1) In home requires physician name, Rx# and authorized refills and be understandable to a lay-person
2) institutional requires time and scheduled administration.
Term
What type of IV administration would be expected to result in the most constant blood level of a drug (least fluctuation)
Definition
Continuous IV
Term
Which route of administration would typically allow the largest volume of fluid to be administered?
Definition
IV
Term
Which needle would be most appropriate for a SQ injection?
Definition
30g 1/2"
Term
(t/f)When reconstituting a hazardous drug, a slight positive pressure inside the vial is desired to prevent environment contamination
Definition
False
Term
(t/f) Employers are required to have an MSDS available for each and every hazard
Definition
True
Term
Appropriate work practices inside the isolator are not necessary to prevent environmental contamination, as the system is closed
Definition
False
Term
(t/f) During hazardous drug compounding, it is necessary to wash hands both before donning gloves and after removal of gloves
Definition
True
Term
(t/f) Attaching and priming the appropriate IV set to the hazardous preparations while still in the BSC/isolator will help reduce the potential for environmental contamination
Definition
True
Term
Your pharmacy is compounding a hazardous drug that colatilizes in a class II BSC that vents HEPA filered exhaust into the room you're working in. Is this system capable of protecting your compounding staff? (why or why not)
Definition
No- HEPA filters don't filter out gas vapor. It needs to be vented out doors
Term
Which type of biologic safety cabinet is preferred by NIOSH for compounding of hazardous drugs that volatilize?
Definition
Class II type B2
Term
Which set of gloves should be used to remove the final hazardous preparation form the isolator and to label it?
Definition
Inner pair, after the vial is cleansed/wiped down
Term
In a buffer room where hazardous preparations are compounded is it preferred that the area be negative pressure or positive pressure (compared to surrounding areas)
Definition
Negative pressure
Term
What is a CSTD?
Definition
Closed-system transfer device
Term
How can a CSTD help increase environmental protection during compounding of hazardous drugs?
Definition
Decreases drug contaminents of hazardous drug thus minimizing exposure to potentially harmful substances
Term
What does MSDS stand for ?
Definition
Material Safety Data Sheet
Term
Name three classes of drugs that may be considered hazardous
Definition
Cytotoxic
Biologics
Antivirals
Term
What two additional pieces of PPI are needed when cleaning up a hazardous spill?
Definition
Face shield and respirator
Term
(t/f) When using a LAFW nothing should interupt the airflow between the HEPA filter and the sterile objects
Definition
True
Term
USP 797 requires the primary engineering components to provide a unidirectional ISO class 7 environment in the direct compounding area
Definition
False- Use Class 5 hood
Term
(t/f) All aseptic manipulations should be performed at least 6" away from the sides and front edge of the LAFW
Definition
True
Term
(t/f) Syringes are accurate to 1/2 the smallest increment marking on the barrel
Definition
True
Term
(t/f) If a vial has an intact flip-top cap, it is not necessary to swab the stopper with an alcohol wipe after the cap is removed.
Definition
False
Term
(t/f) if the blower of a LAFW is off, it's acceptable to begin compounding sterile preparations as soon as the blower is turned back on.
Definition
False- must wait 30 minutes
Term
(t/f) USP 797 stipulates that personnel that will compound CSPs must demonstrate their competence by both written test and media fill testing
Definition
True
Term
(t/f) To ensure fluid transfer from a syringe into an IV bag, a needle longer than 3/8" should be used.
Definition
True
Term
Normally a LAFW needs to be tested and certified every 6 months. Name two reasons that would necessitate the LAFW be tested before the 6mo period.
Definition
1) LAFW is moved
2) If filter damage is suspected
Term
To maintain sterility during aseptic compounding, which two parts of a syringe should you never touch?
Definition
1) tip
2) punger
Term
The volume of fluid to be removed from a vial should be replaced with an equal volume of ____________ to avoid creating a vacuum
Definition
Air
Term
Aseptic technique describes the methods used to __________________
Definition
Manipulate sterile products so that they remain sterile
Term
Pleas provide the USP 797 definition of "first air"
Definition
The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free
Term
Please describe the technique used to minimize the risk of "coring" when inserting a needle through a rubber stopper
Definition
Pierce the stopper with the bevel tip and apply lateral pressure so the heel of the bevel enters the stopper through the same hold the tip made
Term
Why is it important to remove air bubbles form the solution inside a syringe during compounding?
Definition
To obtain an accurate measurement
Term
(t/f) Artificial nails are more likely to harbor gram-negative pathogens than natural nails, both before and after handwashing
Definition
True
Term
(t/f) All compounding personnel must successfully complete an initial gloved fingertip/thumb sampling procedure no less than three times before compounding CSP's for human use
Definition
True
Term
(t/f) Touching the critical sites of sterile components while compounding is the most common source of contamination of compounded sterile preparations.
Definition
True
Term
List some critical sites
Definition
Needle
Hub
Vial septum
Term
(t/f) A media fill test must be performed annually for each staff member that compounds low or medium risk preparations.
Definition
True
Term
(t/f) Used coats, masks and hats may be stored in the anteroom for reuse, but must be discarded at the end of the shift.
Definition
False- only coats may be reused
Term
Name 4 disadvantages of administering a drug via the parenteral route
Definition
1) more difficult/costly to produce
2) cannot be removed easily from body if problems
3) May be painful or cause tissue damage
4) Introdxn of pathogens can be serious
Term
What is the fxn of a laminar airflow workbench?
Definition
Provide an aseptic work area by constantly sweeping the work area with specially filtered air
Term
What is the pH of normal human serum?
Definition
7.4
Term
How many skin particles typically shed from a human body per hour?
Definition
1,000,000 (10^6) or more/hr
Term
Name four conditions that cause the human body to shed more than the typical amount of skin particles per hour
Definition
1) rash
2) sunburn
3) weeping sores
4) use of cosmetics
Term
If a steril compounding pharmacy receives a bulk container of powered drug with no expiration date, how long may the product be used for?
Definition
1yr after the date of receipt unless testing indicates other wise
Term
Name 4 reasons why a drug may need to be delivered by the parenteral route
Definition
1) immediate drug action needed
2) needs direct delivery (organ/nerve etc)
3) Fluids/elytes/nutrition can't be delivered oral
4) superior therapy/conveniance
Term
If a plastic polymer is used as a container for a sterile preparation, what are three problems that it may present?
Definition
1) permeation of vapors/molecules through container
2) leaching of plastic components into preparation
3) Adsorption of drug molecules into the plastic
Term
Why are antimicrobial scrub brushes not recommended for hand cleaning prior to sterile compounding?
Definition
Because they can cause skin irritation/damage
Term
Why are antimicrobial scrub brushes not recommended for hand cleaning prior to sterile compounding?
Definition
They can cause skin irritation/damage
Term
What are the seven steps to garbing for compounding?
Definition
1) remove all outer garments
2) shoe covers
3) head and facial hair covers
4) Face mask
5) hand wash
6) gown
7) antiseptic hand cleaning
8) Sterile gloves
Term
(t/f) USP chapter 1191 states that it is the pharmacists responsibility to ensure that drug products provided to pt meet acceptable criteria of stability
Definition
True
Term
(t/f) USP 797 requires multi-dose vials to be discarded 28 days after the vial has been opened (unless manufacturer specifies otherwise
Definition
True
Term
(t/f)Data exists supporting Drug A stability for 30 days at refrigerated temp. If drug A is compounded as a low-risk level CSP with no sterility testing, the max BUD at refrigeration would be 14days
Definition
True
Term
(t/f) Drugs tend to interact less with glass than plastic storage containers
Definition
True
Term
(t/f) USP risk level category for a given sterile activity is assigned according to the corresponding probability of contamination
Definition
True
Term
(t/f) For a medium-risk CSP, if a company performs sterility/stability tests that show product is stable and sterile for 14 days at room temp then the product can be labeled as such.
Definition
True
Term
What percentage of active drug has been lost at time of a commercial products expiration date?
Definition
10%
Term
Why do lipid emulsion products need to be stored in a glass or non-PVC container
Definition
Lipid emultions extract plasticizers d-2-ethylhexylphthalate (DEHP) and makes toxic hydroperoxides
Term
What is the definition of "stability" per USP 1191?
Definition
The extent to which a product retains, within spcified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of its manufacture
Term
Why does a manufacturer establish a "maximum useage time" for a product packaged in a PVC container. After the product is removed from its commercial over-wrap?
Definition
Term
For low-risk level CSP in the absence of any sterility test what is the maximum BUD for the product if it is stored at room temp prior to administration?
Definition
48hr
Term
What does BUD stand for? What two factors are used to determine a BUD?
Definition
Beyond use date
Stability and Sterility
Term
What pore size filter must be used during high-risk level compounding to provide terminal sterilization of the product?
Definition
0.22 micron
Term
What are the four types of parenteral administration?
Definition
Intraderma
Subq
IM
IV
Term
What are the three types of IV administration?
Definition
Continuous
Intermittent
IV push or bolus
Term
Intradermal Injections (ID)
Location, Vol, Needle, Use
Definition
Location: between dermis and epidermis
Volume: 0.02-0.5ml
Needle size: 25-31g 3/8 to 5/8"
Use: PPD
Term
SubQ location, volume, needle size and use
Definition
Location: SubQ fat between dermis and muscle
Vol: up to 1ml
Needle: 25-32g 1/2-5/8"
Use: Insulin, B12, vaccinations
Term
IM injection location, volume, needle size
Definition
Location: muscle mass ie. deltoid, gluteus maximus, vastus lateralis
Vol: Adults- 2ml delt and 5ml glute
Children < 3yo MAX of 1ml
Needle: 20-23g (smaller breaks) (1/2)-(1-1/2")
Term
IV location, volume and needle size
Definition
Location: veins
Volume: 3L/day
Needle: 20-23g 1/2- (1-1/2)"
Term
What is the only muscle that you can give a child < 18mo an IM shot in?
Definition
Vastus lateralis
Term
What are some advantages of Cont. IV?
Definition
FLuid and drug admin at same time
Constant blood level of drug
Minimize vein irritation
Less expensive
Term
What are some disadvantages of Cont IV?
Definition
Requires monitoring
Stability my preclude hang time
Term
Intermittent IV advantages
Definition
Less monitoring (only over 15min)
Less possibility for toxicity than IV push (diluted)
Term
What are some disadvantages to Intermittent IV?
Definition
Drug levels less constant
May be impractical for emergency
Term
IV push/bolus advantages
Definition
Immediate injection- good in EMERGENCY
requires little monitoring
least expensive
Term
What are some disadvantages of IV push or bolus?
Definition
Drug may be more irritating in high conc
Drug stability may preclude high conc
Dose requires additional time for RN
Term
What is a PIV?
Definition
Peripheral IV
Term
What is a PICC?
Definition
Peripherally inserted central catheter
Term
What is a hickman/broviac?
Definition
Surgically placed intra-jugular (central) with 1-3 lumens
Term
What is a groshong catheter?
Definition
Similar to H/B, placed surgically intra-jugular but no daily heparin needed (check valve)
Term
What is a port?
Definition
Surgically implanted central line to vena cava that requires huber needle access
Term
What is important to remember when you overfill a syringe?
Definition
Label overfill volume on syringe
Term
When is a label not nessicary?
Definition
Only when preparation is administered immediately and admin by the preparer
Term
Labels must be easy to read and understand
Definition
Term
What are 3 guidelines for labeling?
Definition
1) printed/typed
2) metric measures
3) med ID w/ full name
Term
What are 7 labeling requiremnets for CSPs per USP?
Definition
1) name (generic) and concentration
2) total volume (specify overfill)
3) BUD (based on stability and sterility
4) Appropriate route/method of admin
5) Sorage (light/temp/shaking)
6) Other safe use info (warnings)
7) Initials of pharmacist
Term
What are some auxillary label indications?
Definition
light protection
final filter required
rate precautions
storage conditions
drug concentration
route of admin
Term
What are patient specific labeling requirements? (institutional)
Definition
Pt Name
Pt ID#
Pt location
Time and date scheduled admin
Term
What are two significant differences of institutional and in-home labeling?
Definition
1) label must be understood by lay person
2) label must meet state board req for pharmacy
Term
What are some patient specific information for in-home labeling?
Definition
Rx #
Presciber
Authorized refills
Pt name
Pt address
directions for Pt use
Name/address/phone of pharmacy
Term
What are some labeling strategies to decrease confusion?
Definition
Tall man letters
Highlighting
Graphics
Term
What are the three key factors to produce CSP?
Definition
1) proper aseptic technique
2) appropriate equipment
3) proper environment
Term
What does DCA stand for?
Definition
Direct compounding area
Term
What is the direct compounding area (DCA)?
Definition
Critical area in ISO class 5 PEC where critical sites are exposed to first air
Term
What is a PEC?
Definition
Primary engineering conrol
Term
Give an example of a PEC?
Definition
ISO class 5 environment
Term
What is corner stone to all PEC?
Definition
HEPA filter
Term
How large is the zone of turbulance?
Definition
3x the air can flow around both sides
6x when air can only flow around one side
Term
What is a major problem with causing a zone of turbulence?
Definition
it can pull contaminated air into the hood/critical sites
Term
How long must a LAFW run before being used?
Definition
30min
Term
How do you clean a LAFW?
Definition
70% isopropyl alcohol from back to front never touching heppa filter grill
Term
What is critical to aseptic technique?
Definition
Hand placement
Term
What range should of syringe should you use?
Definition
20-75% of volume should be utilized for accuracy and safety
Term
Why should you never wipe a needle with alcohol?
Definition
lubricated
Term
What length do needles range from/to?
Definition
3/8-3"
Term
What gauge do needles range from/to?
Definition
13-31g
Term
When should you not replace volume removed from a vial with air?
Definition
when drug forms a gas (ceftazadine)
Term
What type of container requires a filter needle?
Definition
Ampules
Term
How long must a needle be to puncture an IV bag? Why?
Definition
LONGER than 3/8 because it has two diaphrams
Term
When did USP 797 come about?
Definition
Jan 1 2004
Term
When are parenteral products used?
Definition
Unable to take PO mes
Drug inactivated by PO route
Immediate drug action required
Site specific delivery required
IM depot admin
Term
What are 6 categories of parenteral products?
Definition
1) solution
2) Dry for reconst
3)suspension
4)Emulsions
5) dry (insoluble) for vehicle
6) liq concentrate for dilution
Term
Parenteral products must be free from pyrogens, particulates and impurities
Definition
Term
What is the tonicity of normal solutions?
Definition
282-288mOsmol/kg
Term
It is possible to get rid of bacteria, but not the endotoxin (pyrogen)
Definition
Term
What size of particle does a HEPA filter remove?
Definition
0.2-0.3 micron
Term
are clean room and buffer room the same?
Definition
yes, where the LAFW is and compounding occures
Term
What are the goals of USP 797?
Definition
Prevent potential harm/death from :
microbial contam
Excessive bact endotoxin
Large content errors in strength
incorrect ingredients
Term
What class of LAFW is an isolator?
Definition
Class III
Term
Where does the air filtering occure on a class I LAFW?
Definition
Only exhausted air
Term
What air on a class II is filtered?
Definition
Intake and exhaust air
Term
how many particles per foot does a ISO class 5 have? per meter?
Definition
100 particles 0.5micron or larger/cu ft
3520 particles 0.5 micron or larger/cu meter
Term
What is the standard for clean room air?
Definition
ISO class 7
Term
HOw many particls/ft does ISO class 7 have? Per meter?
Definition
10K
352K
Term
What is standard air for anteroom?
Definition
ISO class 8
Term
How many particles per ft is ISO class 8? Per meter?
Definition
100K
3,520K
Term
What are some antimicrobial cleansing products?
Definition
Isopropyl and ethyl alcohols
Chlorhexidine gluconate
chloroxylenol
Iodophors
Quaternary ammonium
Term
What antimicrobial cleansing product has not yet been found to be safe and effetive by the FDA?
Definition
Triclosan
Term
What must gloves NOT have for compounding CSP?
Definition
powder
Term
What are three types of gloves available and notable features?
Definition
Latex- allergies
Vinyl- least expensive
Nitrile- stronger
Term
Should you wash hands after you remove your gloves?
Definition
Yes
Term
What can hazardous drugs exhibit?
Definition
Genotoxicity
Carcinogenicity
Teratogenicity
Ferility impairment
Organ or other toxicity at low doses
Term
All hazardous drugs must be clearly labeled and should be separated from other drugs in bins
Definition
Term
What must staff wear while handeling hazardous drug stock?
Definition
Gloves
Term
What air pressure environment is preferred in compounding of Hazardous drugs?
Definition
Negative air pressure
Term
What type of hood/ventilation is required for hazardous compunds?
Definition
Class II biological safety cabinet
Outside venting system
Term
What cabinet should be used for volatile hazardous substances?
Definition
Class II type B2
Term
What type of cabinet is OK for hazardous compounds that aren't volatile?
Definition
Class II A2
Term
What is a class III BSC?
Definition
Bio safety cabinet with gauntlets, isolator completely sealed
Term
Does a class III bsc still need negative pressure for hazardous drugs?
Definition
Yes
Term
How often should gloves be replaced when comounding hazardous materials?
Definition
every 30 minutes
also double glove!
Term
How often shoudl coated gowns be changed in hazardous compounding?
Definition
every 3 hrs, non coated more freq
Term
What additional PPI might be needed if potential for spash or aerosolization is present in hazardous compunds?
Definition
Respirator and face shield
Term
Where should attachment and priming of IV set occure on hazardous compounds?
Definition
In BSC to avoid environmental contamination
Term
Do not remove IV set from bag of hazardous comound when infusion is complete
Definition
Term
What should you do when reconsituting a hazardous compound vial?
Definition
create slight negative pressure
Term
What do you use as a deactivating agent for hazardous compounds?
Definition
sodium hypochlorite (bleach)
Thiosulfate to neutralize bleach and deactivate non oxidizable agents
Term
HOw often should workers handeling hazardous drugs get a physical and lab w/ CBC, liver and urinalysis?
Definition
every 1-2yrs
Term
What must BUD be based on?
Definition
professional experience adn interpretation of reliable sources
Term
Whos responsibility is it to ensure stability and sterility until the date specified?
Definition
Pharmacists
Term
What is sorption?
Definition
Drug lost to container
Term
What two substances can cause a nasty precipitate in IV?
Definition
Calcium and phosphate
Term
What are 3 physical stability problems?
Definition
1) drug present but altered
2) precipatate
3) adsorption/absorption
Term
What are chemical stability concerns?
Definition
Acid-base
Oxidation-rdxn
displacement
gas release
Term
What are some environmental factors that can adversly effet stability?
Definition
temp, light, humidity, oxygen, CO2
Term
What are the three contamination risk levels?
Definition
Low
Medium
high
Term
What are some risk considerations for transport of CSP?
Definition
storage, shipping, containers
Term
Where do we get sterility data?
Definition
USP 797
Term
Where do we get stability data?
Definition
Trissels
Kings
Lab testing
Term
If a facility isn't up to 797 it can produce products good for 12hr
Definition
Term
Low risk CSP criteria
Definition
No more than 3 products mixed
No more than 2 entries into any 1 container
Term
Low risk CSP sterility dating
Definition
Room: 48h
Cold: 14d
Froze: 45d
Term
Medium risk CSP criteria
Definition
Admin to multi Pt or Pt occassion
Process is unusally long/complex
OR stuck more than 2 times or more than 3 products
Term
Medium risk CSP dating
Definition
Room: 30hr
Cold: 9d
Frozen: 45d
Term
High risk CSP criteria
Definition
non-sterile ingredients
exposure air poorer than ISO Class 5 for more than 1hr
Improper garbing, non sterile water
Term
What sterilizaton process must a high risk CSP go through?
Definition
filtration through 0.22micron filter
Term
How often does a media fill test have to be done for high risk CSP?
Definition
Semiannually
Term
High risk CSP dating
Definition
Room: 24h
Cold: 3d
Frozen: 45d
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