Law final exam: USP Flashcards
<795> Training and Evaluation Competencies
what are the 6 competancies
Have a
Great
Christmas & Sing
Happy tunes,
Michelle
Pray
Passionately
Hand Hygiene
Garbing
Cleaning and sanitizing
Handling and transporting components
Measuring and mixing
Proper use of equipment
Proper documentation
<795> Steps of Training Process
what are the 2 types of safety documents
what does SOP stand for
Safety Documents:
*Safety Data Sheet (SDS)
- a detailed informational document prepared by the manufacturer or importer of a hazardous chemical. It describes the physical and chemical properties of the product.
*Certificates of Analysis (COA)
- a formal laboratory-prepared document that details the results of one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses
Standard Operating Procedures (SOP)
- provides clear-cut directions and detailed instructions needed to perform a specific task or operation consistently and efficiently.
<795> Personnel Preparation
what must you remove
- outer
- rings..
- music
Hand Hygiene
- what must you wash your hands with
- how long must you wash your hands
- what must you dry your hands with
removed
- outer garments
- Jewelry including piercings
- Earbuds or headphones
Hand Hygiene
- Wash hands soap and water
- 30 seconds minimum
- Dry hands with disposable towels
<795> Garbing
what must be worn for all compounding
additional PPE may be needed, what are they
Gloves
– Must be worn for all compounding
Additional personal protective equipment (PPE) as needed depending on the compound and risk of chemical exposure to the compounder:
Shoe covers
Head or hair cover
Facial hair cover
Face mask
Gown
*If the compounding is for a hazardous compound USP 800 PPE requirements are
<795> Facility Requirements
what must the space for compounding be
- separate from what
- should it be messy and disorganized
- do you need a water source and if so what kind of water to be used for what
what must the facility have in order to be environmentally appropriate
- light
- temp and humidity
- temp. monitoring for what
- easily cleanable what
Space for compounding only
– Must be separate from sterile compounding
– Must be clean and organized
– Need a water source for cleaning
■ Purified water should be used to clean equipment and for any preparations requiring water
Environmentally appropriate
■ Good lighting
■ Appropriate temperature and humidity
■ Temperature monitoring daily for excursions of chemical storage
■ Easily cleanable floor, non- porous
<795> Equipment
Must be in _____ and appropriate for _____ being made
if compounds can cause airborne chemical particles, what device must be used
what are the 2 types of closed-system processing devices to be added
how often should ventilation systems be certified?
Must be in good condition and appropriate for compounds being made
If compounds could cause airborne chemical particles a closed-system processing device needs to be added to this area.
– Containment ventilated enclosure (CVE)
– Biological Safety Cabinet (BSC)
■ Ventilation for these systems must be certified every 12 months
<795> Cleaning Schedules
what must be cleaned if there is Visible soiled or suspected contamination
what must be cleaned after the spill
what must be cleaned every 3 months
what must be cleaned every 24 hours
what must be cleaned between compounds
Visible soiled or suspected contamination
- ceiling and walls
- Storage Shelving
- Floors
- Work Surfaces including Closed- System Processing Devices
after spill
- Storage Shelving
- Floors
- Work Surfaces including Closed- System Processing Devices
clean every 3 months
- Storage Shelving
clean every 24 hours
- Floors
- Work Surfaces including Closed- Closed-system processing Devices
clean Between compounds
- Work Surfaces including Closed- System Processing Devices
Expiration Date versus Beyond Use Date
who determines expiration dates, based on what and when would April 2024 expire
when is BUD determined and by what 3 standards are they based on
what is the USP-NF, what is available through it and what does it include
Expiration Date
– Determined by manufacturer based on product stability for package insert stated conditions
■ April 2024 is April 30th, 2024
Beyond Use Date (BUD)
– After manipulation of a product
– Determined by:
■ Stability (chemical and physical) this can be affected by planned storage conditions
■ Compatibility with storage containers
■ Potential for microbial proliferation
United States Pharmacopeia – National Formulary (USP-NF)
– 5000+ standards for chemical and biologic: active pharmaceutical ingredients (APIs) and excipients
■ Monographs are available for many compounding recipes and include BUDs
<795> Master Formulation Record
what is this considered to be
what should it include?
- do you need the name, strenght and dosage form
- do you need the materials that it is made with
- what information do you need
for BUD, what must be included
- what is needed
- what kind of instructions are needed
- what information is needed to which the examples are final product, pH, viscosity etc
- requirements on storage?
How the compounds are made – considered to be your recipe!
This should include:
– Name, strength, and dosage form
– Ingredients required
– Calculations and quantity required of each ingredient
– Compatibility and stability information
Beyond Use Dating
– Equipment and supplies needed
– Mixing instructions – times, amounts, temperatures, techniques
– Quality Control Information (e.g. final product description, pH, viscosity, etc.)
– Storage Requirements
<795> Labeling Requirements
what must be included in a label
upon dispensing of the compound, additional label must include what
what may be required and based on what
After the compound is complete label must include:
– All active ingredients, amounts, strengths, concentrations
– Total volume of compound
– Beyond Use Date (BUD)
– Dosage form
– Storage information if other than controlled room temperature
– Internal identification number (e.g. barcode, prescription, order, or lot number)
Upon dispensing of the compound additional label must include:
– Route of administration
– Indication
– Special handling or warnings if applicable
■ Additional labeling requirements may be required based on your state laws or facility SOPs.
what is Quality Assurance
what is Quality Control
what is the purpose of both
Quality Assurance
– A system that ensures the compounding process consistently meeting the quality standards.
Quality Control
– Sampling, testing, and documentation of results to show the specific parameters are met for the compound prior to its use.
Adherence to the procedure, Prevention, and detection of errors, Quality product, Follow up on adverse events or complaints
<797> Training and Evaluation competancies
Have a
Great
Christmas & dance
Count many miracles
Always
Accept & maintain smile
Use of what
Proper what
Principles of HEPA
Proper use of PEC
Principles of movement of ____ and ____ in compounding area
Hand Hygiene
Garbing
Cleaning and disinfection
Calculations, measuring and mixing
Aseptic technique
Achieving and maintaining sterility
Use of equipment
Proper documentation
Principles of high-efficiency particulate air (HEPA)
Proper use of primary engineering control (PEC)
Principles of movement of materials and personnel in compounding area
<797> Steps of Training Process
what is assessed for technique assessment
___ with what fingers
how many times is this done
what is also assessed in regards to media
what is SOP
USP <797>
Technique Assessment
* Garbing with fingertip and thumb sampling - done 3 times
* Aseptic with media fill (use growth media)
Standard Operating Procedures (SOP)
<797> Personnel Preparation
Remove
- outer
- rings
- all __devices
- makeup
- nail
hand hygiene
- where should you clean under
- where should you wash up to
- how long should you scrub
- what should you dry with
hand sanitization
- what is the base of the hand rub
- what must you cover
- should they be dried partially
Remove
- Outer garments
- Jewelry including piercings
- All electric devices
- Cosmetics
- Artificial nails and nail polish
Hand Hygiene
- Clean underneath fingernails with a disposable cleaner.
- Wash hands and forearms up to elbows with soap and water
- scrubbing for 30 seconds minimum
- Dry hands and forearms with low-disposable towels
Hand Sanitization
- Alcohol-based hand rub
- Cover all surfaces and fingernails
- Allow to dry completely
Garbing Order
H
F
S
H
G
H
G
70%
Hair Cover (head and face)
Face mask
Shoe covers
Hand hygiene
Gown
Hand Sanitization
Gloves
70% isopropyl alcohol spray
<797> Control Engineering
what are the two types of primary control
in what situations is vertical vs horizontal air flow better
Primary Control
– Laminar Air Flow Workbench (LAFW)
■ Vertical and Horizontal
HEPA filters are placed to filter in air that comes into the hood
vertical works well for HD because air does not come at you
horizontal blows air toward you away from a compound that you are making
<797> Other Types of Primary Engineering
Control (PEC)
what are the 3 other types
difference between primary and secondary control
so in total how many types of PECs are there
Compounding aseptic isolator (CAI)
Compounding aseptic containment isolator (CACI)
the isolators are machines where you put your compound material into and after you GARB you put your arms through and work with your compound
Biological Safety Cabinet (BSC)
difference between primary and secondary engineering control:
ante-areas and buffer areas or cleanrooms are known collectively as secondary engineering controls (SECs) because they provide the controlled environments in which PECs (laminar air flow workbenches [LAFWs], biological safety cabinets [BSCs], and compounding isolators) are placed.
types of PECs
- biological safety cabinet
- compound aseptic isolator (CAI)
- compound aseptic containment isolator (CACI)
- Laminar air flow workbench
<797> Secondary Controls
The buffer area also houses what, what is ISO
what is the ante area, what happens in this area, what is the ISO
what ISO is the primary engineering control
- Buffer Area - the room where Primary Engineering Control is located, kept as clean as possible
ISO 7 or better
Ante area - prep area before compounding, GARB up, hand hygiene
- ISO 8 or better
Primary Engineering Control is ISO 5 or better
International Organization of Standards (ISO) Classification
where do particles come from
what are particle limits maintained through
ISO classification means
Particles come from:
* People
* Garments, makeup, jewelry, skin
* Paper Products
* Dust and Dirt
Particle limits are maintained through:
* Garbing procedures, no makeup, no jewelry
* Air Flow pressure settings
* Filtration – HEPA filters
number of particulates, trends down and want lowest number in primary control
Air Flow
it is another way to control what
what do different rooms have
what is positive pressure used for
what is negative pressure used for
another way to control airflow entry annd the number of particulates is by using airflow
we have rooms with different pressure amounts and control what is going in and out of the spaces using compound
positive pressure:
- used in a typical non-hazardous, increased room pressure in the buffer room and pushes out into ANTE area - pushes particulates and microbes to the ANTE area
negative pressure:
- used for hazardous materials
- hood ventilation is also pulling outside and through filters away from the compounder
- assuming that it pushes air into the PEC (?)
<797> Compounded Sterile Products (CPSs)
3 categories of compounds- denoted by the controlled environment they are compounded in
Category 1
- Least controlled environmental conditions
- Lowest BUD
Example:
Immediate use product
Category 2
- More environmental control and testing
- Longer BUD than Category 1
- more certain that there are no microbes growing the product
Example:
- Typical intravenous compounding in a primary control setting
Category 3
- Highest level of environmental control required and extensive testing of products
- Longer BUD than Category 1 and 2
Example:
- Higher risk compounding with products requiring lots of manipulation.
<797> Certification of Classified Areas and PEC
what must be tested
what filter must be tested
what count must be tested
what pattern must be tested
Airflow Testing
HEPA Filter Integrity Testing
Total Particle Count Testing
Dynamic Airflow Smoke Pattern Testing
<797> Microbial and Particle Monitoring
Air and Surface Monitoring
- Evaluation of results allow for what
- where should sampling of a pharmacy be done
- what must each facility have
Facilities are required to perform these tests when:
- after opening what
- after servicing what
- in response to what
- after any changes to what
Air and Surface Monitoring
– Evaluation of results allow for adjustment to equipment, protocols, or training
– Sampling of the pharmacy should be completed in a dynamic working environment to show real world compounding data
– Each facility must have a plan for obtaining this data and documenting the results and actions related to the results
Facilities are required to perform these tests when:
– Opening a new compounding space
– After servicing of facility or equipment
– After identified problem on previous testing
– In response to any trends that may indicate you are heading towards a problem
– After any changes are done to the compounding area, SOPs, or chemical cleaning agents
<797> Cleaning Steps
Cleaning
* Contains surfactant to remove dirt and debris
disinfectant
* Destroys fungi, viruses, and bacteria
Sporicidal
* Destroys bacterial and fungal spores
minimum do these steps at least once a day
if working with level 3 organisms then do step 3 more often
<797> Cleaning Schedule with 70% Isopropyl Alcohol after cleaning steps
Workbench Surface – Primary Engineering Control (PEC)
– Start of each shift
– Before each batch
– At least every 30 minutes when compounding unless your compounded product takes longer than 30 minutes than immediately after completing the product
– After spills
– Surface contamination is suspected
<797> Cleaning Schedule
for buffer and ante rooms
what must be cleaned daily
- what is not included in this
what must be cleaned monthly
- for shelving, what must be removed and then cleaned
Buffer and Ante Rooms
– Daily
■ Trash
■ Floors
■ Counters
– Not including the primary control workbench
– Monthly
■ Ceilings
■ Walls
■ Storage Shelving
– Shelving – all content must be removed and then cleaned
*for high risk compounding facilities this may be done more frequently
<797> Immediate Use Compounds
Definition – Low-risk preparation for immediate administration, harm to the patient if the product is delayed
■ Product can be mixed outside of the Primary Engineering Control (PEC) system
■ Must meet the criteria below to fit this category:
– Personnel are trained in USP 797 and demonstrate competency in aseptic processes
– Final product contains no more than 3 ingredients
– Administration within 4 hour
– Must have a label added to the product
factors that are looked at when determining BUD :)
what do they consider when assigning BUD?
category 1
- environment
- Storage conditions (e.g. controlled room, refrigerator)
category 2
- Environment
- Storage conditions (e.g. controlled room, refrigerator)
- Compounding method
- Sterility testing is being done
- Starting compounding components (sterile vs nonsterile)
category 3
- Environment
- Storage conditions (e.g. controlled room, refrigerator)
- Compounding method
- Sterility testing is being done
- Starting compounding components (sterile vs nonsterile)
Factors that can help extend BUD (also under category 3)
- Increase the use of sporicidal disinfectants
- Increase in environmental monitoring
- Stability determination data
- Personnel training and qualifications
<797> Master Formulation Record
This should include:
– Name, strength, and dosage form
– All Ingredients and characteristics if applicable
– Type and size of container closure system
– Complete instructions including equipment, supplies, description of each step and any special precautions
– Physical description of final product
– Reference source to support the stability of the CSP
– Beyond Use Date (BUD) and storage requirements
– Other information as needed (e.g. sterilization method used)
no need to memorize list
just know that there is a master form. record, additional pieces to include for 797 and not 795
– Type and size of container closure system
– Physical description of final product
– Reference source to support the stability of the CSP
<797> Compounding Record
what should the products received include
When product was made, by whom, and other trackable information
■ Should include:
– Name, strength, and dosage form
– Master formulary reference
– Components
■ Name, quantity (weight or volume), strength or activity, source/manufacturer, lot number, expiration dates
– Total quantity compounded
– Identity of compounder and person completing the final check
– Date made
– Final yield (e.g. number of units, containers, etc.)
– Control number or prescription number
– Beyond Use Date (BUD) and storage requirements
– Quality control information (e.g. visual inspection, filter integrity testing, pH testing, etc.)
– Calculations made to determine quantities and/or concentrations
<797> Labeling Requirements
After compounding is complete, what must the label include:
Upon dispensing of the compound additional label must include:
After compound complete label must include:
– All active ingredients, amounts, strengths, concentrations
– Total volume of compound
– Beyond Use Date (BUD)
– Dosage form
– Storage information if other than controlled room temperature
– Internal identification number (e.g. barcode, prescription, order, or lot number)
Upon dispensing of the compound additional label must include:
– Patient name and indentifiers
– Route of administration
– Administration instructions
– Special handling or warnings if applicable
Additional labeling requirements may be required based on your state laws or facility SOPs.
USP 800
Hazardous Drug (HD) Types
what does each mean
Genotoxicity
■ Organ toxicity
■ Teratogenicity
■ Reproductive toxicity
■ Carcinogenicity
Genotoxicity
– Potential to damage DNAcan lead to cancer
■ Organ toxicity
– Potential to cause damage to an organ
at low doses
■ Teratogenicity
– Potential to fetal harm
■ Reproductive toxicity
– Potential to cause damage to the
reproductive organs
■ Carcinogenicity
– Potential to cause cancer
<800> Receiving
after receiving, HDs should be
- visibly inspect for what
- separated from what
- unpackaged and immediately placed where
- what should be worn when opening and removing content from packages
HDs should be
– Visibly inspected for damage
– Separated from other medications
– Unpackaged and immediately placed in a HD storage area
– Appropriate personal protective equipment should be worn when opening and removing content from packages
<800> Storage
should HDs be assessed? If so, for.what
- how should HDs that require manipulation be stored
- how should HDs that are single dose packaged and do not required manipulation be stored
should HDs be stored in way that prevents spills, leaks or breakage if container falls? If so, where must they not be stored on
- what are a good option for shelving
HDs should be:
– Assessed for risk
■ HD that require manipulation should be stored away from other drugs
■ HD that are single dose packaged and do not require manipulation can be stored with non-HDs
– Stored in a way that prevents spills, leaks, or breakage if the container falls
■ They can not be stored on the floor.
■ Shelving with raised lips on the front are a good option
<800> Compounding
-what should compounding persons wear that includes what
- what does american society for testing and materials have
what should be worn if there is a risk of dust or debris
what there is concern of vaporization of med. what is required
– Negative pressure technique for ___ compounding should be used or a ____ system ____ device (CSTD) should be used to prevent ____ of HD
Persons compounding HD:
– Should wear personal protective equipment (PPE) including a chemotherapy gown, two pairs of shoe covers, and two sets of chemotherapy gloves
American Society for Testing and Materials (ASTM) – standards for chemotherapy designation
If there is a risk of dust or debris a N95 mask is required
If there is concern about the vaporization of medication a respirator is required
– Negative pressure technique for IV compounding should be used or a closed system transfer device (CSTD) should be used to prevent contamination of HD - aseptic technique
<800> Compounding Area Requirements
where should an HD sterile preparation be done
what does ISO 7 maintain
where should an HD non-sterile preparation be done to prevent the spread of HD
HD Sterile Preparation:
– In a negative pressure area to prevent the spread of hazardous materials
– Ante Room
Required to be ISO Class 7 – this to maintain the negative pressure environment to prevent the spread of HD particles
HD Nonsterile Preparations:
– Containment ventilated enclosure or biological safety cabinet need to be used to prevent the spread of HD
■ This is different than non-HD
■ Required to be ISO Class 5
<800> Dispensing
how should All HD be:
- labeled stating what
- labeled for antineoplastics
IV ports be sealed to provide what and prevent what
All HD should be:
– Labeled stating “Caution: Hazardous Drug”
– All antineoplastics (chemotherapy agents) should be labeled with “Chemotherapy – Dispose of Properly”
– IV ports can be sealed to provide a physical barrier and prevent leakage
<800> Administration
Administrator should:
– Wear proper PPE
■ All antineoplastics require two pairs of chemotherapy gloves
– If an injectable this also requires a chemotherapy gown
– Single pair of glove is acceptable if it is a intact tablet or capsule
■ Single pair of gloves should be worn for other types of HD
<800> Disposal
all PPE worn is considered to be what
what cannot be discarded in regular trash
Yellow Disposal Bins – Trace HD
– All PPE worn during compounding is considered contaminated
■ Inner gloves and inner shoe covers are not and can be discarded in the regular trash
– Empty vials, syringes, IV bags, IV tubes
■ Black Disposal Bins – Bulk HD
– Unused or partially empty vials, syringes, IV bags
<800> Sanitization
what do you use for Deactivation/Decontamination
what does it do
what do you use for cleaning
what does it do
what do you use for disinfection
what does it do
Deactivation/Decontamination
*2% sterile bleach or peroxide
*Reduces toxicity and removes HD residue
- break down the chemical structure
Cleaning
*Germicidal Detergent
*Removes dirt and microbe contamination
Disinfection
*70% Sterile Isopropyl alcohol (IPA)
*Inhibits or destroys microbes.
<800> Training Requirements
Prior to the start of the position and then at least annually (every 12 months) what must occur
- prior to what
- is it for old or new equipment being used
- what must be obtained for all workers and what must it acknowledge
Prior to the start of the position and then at least annually (every 12 months)
– Additional training should occur:
■ Prior to new protocols or processes going into effect
■ New equipment being used
■ A consent form for all workers should be obtained acknowledging the risks of handling HD.
USP 797
Air Exposure Time In and Out of PEC
opening vials and maybe we do not use all of it, so if we open it how long is it good for or is there a time frame
different types of products
Ampule - if you open it, use it immediately
Inside ISO 5 PEC & Outside ISO 5 PEC
- Immediate use only
Single-dose vial
Inside ISO 5 PEC: 12 hours
Outside ISO 5 PEC: 0 seconds
Pharmacy bulk package
Inside ISO 5 PEC: 12 hours
Outside ISO 5 PEC: 0 seconds
Multi-dose vial - has antimicrobial agents
Inside ISO 5 PEC: 28 days
Outside ISO 5 PEC: 28 days
Each medication should be checked with the package insert at the manufacturer’s directions. Some medications may have a shorter timeframe.
Multi-dose vials have preservatives in them allowing for an extended time.
Aw
water activity
*Master Formulation Record
Recipe to make the compound
*Compounding Record –
Record of making the product
