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
|
|
Term
| (t/f)It is preferred to label a compounded product with brand and trade name of the active drug |
|
Definition
|
|
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
|
|
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
|
|
Term
| For a 6mo old baby receiving routine vaccinations which is the preferred muscle for an IM injection? |
|
Definition
|
|
Term
| For a 6mo old baby receiving an IM injection what would be the max volume aloud for each IM injection? |
|
Definition
|
|
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
|
|
Term
| What two pieces of information must be considered when assigning a BUD on a compounded sterile products label? |
|
Definition
|
|
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
|
|
Term
| Which route of administration would typically allow the largest volume of fluid to be administered? |
|
Definition
|
|
Term
| Which needle would be most appropriate for a SQ injection? |
|
Definition
|
|
Term
| (t/f)When reconstituting a hazardous drug, a slight positive pressure inside the vial is desired to prevent environment contamination |
|
Definition
|
|
Term
| (t/f) Employers are required to have an MSDS available for each and every hazard |
|
Definition
|
|
Term
| Appropriate work practices inside the isolator are not necessary to prevent environmental contamination, as the system is closed |
|
Definition
|
|
Term
| (t/f) During hazardous drug compounding, it is necessary to wash hands both before donning gloves and after removal of gloves |
|
Definition
|
|
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
|
|
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
|
|
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
|
|
Term
|
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
|
|
Term
| USP 797 requires the primary engineering components to provide a unidirectional ISO class 7 environment in the direct compounding area |
|
Definition
|
|
Term
| (t/f) All aseptic manipulations should be performed at least 6" away from the sides and front edge of the LAFW |
|
Definition
|
|
Term
| (t/f) Syringes are accurate to 1/2 the smallest increment marking on the barrel |
|
Definition
|
|
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
|
|
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
|
|
Term
| (t/f) To ensure fluid transfer from a syringe into an IV bag, a needle longer than 3/8" should be used. |
|
Definition
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Term
| (t/f) Touching the critical sites of sterile components while compounding is the most common source of contamination of compounded sterile preparations. |
|
Definition
|
|
Term
|
Definition
|
|
Term
| (t/f) A media fill test must be performed annually for each staff member that compounds low or medium risk preparations. |
|
Definition
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Term
| (t/f) Drugs tend to interact less with glass than plastic storage containers |
|
Definition
|
|
Term
| (t/f) USP risk level category for a given sterile activity is assigned according to the corresponding probability of contamination |
|
Definition
|
|
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
|
|
Term
| What percentage of active drug has been lost at time of a commercial products expiration date? |
|
Definition
|
|
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
|
|
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
|
|
Term
| What are the four types of parenteral administration? |
|
Definition
|
|
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
|
|
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
|
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
|
Definition
|
|
Term
|
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
|
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
|
Definition
|
|
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
|
Definition
| Primary engineering conrol |
|
|
Term
| Give an example of a PEC? |
|
Definition
|
|
Term
| What is corner stone to all PEC? |
|
Definition
|
|
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
|
|
Term
|
Definition
| 70% isopropyl alcohol from back to front never touching heppa filter grill |
|
|
Term
| What is critical to aseptic technique? |
|
Definition
|
|
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
|
|
Term
| What length do needles range from/to? |
|
Definition
|
|
Term
| What gauge do needles range from/to? |
|
Definition
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Term
| Where does the air filtering occure on a class I LAFW? |
|
Definition
|
|
Term
| What air on a class II is filtered? |
|
Definition
|
|
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
|
|
Term
| HOw many particls/ft does ISO class 7 have? Per meter? |
|
Definition
|
|
Term
| What is standard air for anteroom? |
|
Definition
|
|
Term
| How many particles per ft is ISO class 8? Per meter? |
|
Definition
|
|
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
|
|
Term
| What must gloves NOT have for compounding CSP? |
|
Definition
|
|
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
|
|
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
|
|
Term
| What air pressure environment is preferred in compounding of Hazardous drugs? |
|
Definition
|
|
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
|
|
Term
| What type of cabinet is OK for hazardous compounds that aren't volatile? |
|
Definition
|
|
Term
|
Definition
| Bio safety cabinet with gauntlets, isolator completely sealed |
|
|
Term
| Does a class III bsc still need negative pressure for hazardous drugs? |
|
Definition
|
|
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
|
|
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
|
|
Term
|
Definition
|
|
Term
| What two substances can cause a nasty precipitate in IV? |
|
Definition
|
|
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
|
|
Term
| What are some risk considerations for transport of CSP? |
|
Definition
| storage, shipping, containers |
|
|
Term
| Where do we get sterility data? |
|
Definition
|
|
Term
| Where do we get stability data? |
|
Definition
|
|
Term
| If a facility isn't up to 797 it can produce products good for 12hr |
|
Definition
|
|
Term
|
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
|
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
|
Definition
Room: 30hr
Cold: 9d
Frozen: 45d |
|
|
Term
|
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
|
|
Term
|
Definition
Room: 24h
Cold: 3d
Frozen: 45d |
|
|
