Learning Objectives Flashcards
Quality Control is:
prospective and refers to processes that can be measured as the product is being produced
Quality Assurance is:
focuses on the end product and involves the evaluation of the final preparation and the facility in which it is compounded
Measure:
i. air quality testing
ii. testing of routine disinfection processes
iii. PPE
iv. review of orders and packages of ingredients for identity and accuracy
v. inspection of products for particulate matter and leakages
vi. inspection for thoroughness of labeling
Design of sterile compounding area:
- ante-area (ISO 7)
- positive pressure buffer area for non-hazardous (ISO 7)
- negative pressure buffer area for hazardous (ISO 5)
Daily monitoring
Temp
Airflow
Humidity
(light and sound)
Primary and secondary controls require:
Re-certification at least every 6 months
Primary:
HEPA filters, airflow patterns, particle counts
Secondary
viable air sampling, nonviable (particle count, airflow, air exchanges per hour)
Documentation of training must include:
completion of didactic instruction, written tests, completion of media fill test, gloved fingertip, and surface sampling
Monitoring:
i. periodic surface sampling
ii. electronic air sampling every 6 months
Describe the three simulation tests required for personnel who compound sterile preparations
a. media fill: simulates most complex preparation personnel would be expected to compound (like our final practical)
b. gloved fingertip test
c. surface sampling
Cite the requirements for end-product testing
a. low and medium risk CSPs (compounded sterile products) do not require testing
b. those that exceed USP beyond use dating limits must be tested for stability
c. high risk CSPs made in batches of 25 or more require sterility testing
Define hazardous drug
chemical for which there is evidence that acute or chronic health effects may occur with exposure; any drug that may involve risks from occupational exposures
Exposures and sources of hazardous drug
- Inhalation, dermal, ingestion, injection
- Vial surface, work surface, administration and waste handling, poor technique
Explain environmental controls for compounding hazardous drugs
a. designate storage locations (ventilated, negative pressure)
b. distinct labels
c. designate preparation area separate from other areas
Discuss the role of primary engineering controls in compounding hazardous drugs
a. present in ISO 7
b. provide ISO 5
c. completely vented outside through HEPA filter
d. must maintain sterility and protect operator
i. manipulating air flow (air barrier)
ii. negative pressure
BSC Class II
- Most ideal
1. open front, dependent on air barrier
2. should be vented 100% outside
BSC Class III
- essentially isolators
- gas-tight unit
- maintained under negative pressure
Compounding Aseptic Containment Isolators (CACI)
- designed to isolate hazardous meds and prevent compounder from being exposed to airborne meds
- unidirectional airflow and vented outside
- cleaning: clean, rinse, disinfect, rinse, gaseous sterilization
Define closed-system vial-transfer devices
a. venting pins – not a true closed system
b. closed-system vial-transfer devices (CSTDs) provide most optimal protection against exposure
i. mechanically prohibit escape of hazardous drugs to the environment
ii. PhaSeal – first FDA approved
PPE must be used for
receiving, shelving, compounding, administration, spill cleaning, waste disposal, and handling of patient waste
Gloves:
i. must be chemotherapy certified
ii. powder-free
iii. always double glove
iv. should be changed every 30min during compounding, immediately when damaged or contaminated, and when operator exits the PEC
v. change outer gloves after final product wipe down, right before labeling
vi. inner gloves should be used to complete labeling and place final preparation into the transport bag
Deactivation
render compound inert or inactive
i. oxidizer (sodium hypochlorite/bleach)
Decontamination
remove inactivated residue
i. sterile alcohol, sterile water, peroxide, bleach
ii. must be done in addition to cleaning and disinfection
iii. alcohol will not deactivate any hazardous drugs
iv. cationic soap dilute bleach sodium thiosulfate (neutralizer)
v. must be done for all medications before shelving
Spills
ii. spill >5mL, call environmental services
iii. skin contact wash for 20min
iv. eye contact wash for 15min
Peds IV Meds - See Lecture Flash Cards
Peds IV Meds - See Lecture Flash Cards
Identify the essential components of TPN orders and labels
All ingredients
Everything in mg/kg
Must include access (osmolarity, concerns with peripheral vs central)
Factors that help stabilize lipid emulsions
i. pH > 5
ii. low dextrose and protein concentrations
iii. low amounts of divalent cations (Ca, Mg)
iv. avoid trivalent cations (iron dextran)
v. ADD LIPIDS LAST
Factors that enhance Ca:P stability
i. gluconate»_space; CaCl2
ii. low Ca:P product
1. Ca(mEq/L) * P(mmol/L) * 1.8
Estimate the osmolarity of a TPN
a. peripheral TPN limit of 900mOsm/L
b. central TPN limit of 1800-2000mOsm/L
Describe the quality assurance measures employed for TPNs
a. filtration
i. 2 in 1 (no lipids) require 0.22-micron filter
ii. 3 in 1 require 1.2-micron filter
b. gravimetric analyses
c. chemical analyses
d. refractometric analyses (limited to 2 in 1 formulations)
Describe the typical outpatient and/or home infusion pharmacy
a. staff: pharmacists, technicians, nurses, dieticians, respiratory therapists, customer service, delivery, clerical and administrative personnel
b. services: antibiotics, chemotherapy, immune globulin, pain management, parenteral nutrition
c. licensure and compliance
d. accreditation – provides assurance of basic level of quality
i. TJC, CHAP, PCAB, HQAA, ACHA, Medicare
See Home Infusion Lecture Flashcards
See Home Infusion Lecture Flashcards
Elastomeric Infusion device (Eclipse)
- range of sizes, minimal nursing labor, no programming errors, ideal for patient mobility, easy admin and disposal
- add diluent first then drug volume second
Vista Basic Pump and Acclaim Infusion Pump
- stationary infusion device attached to a pole for large volumes
- non-ambulatory
iii. Cadd Infusion Pump
- ambulatory lightweight pump
Measure syringe dead space
a. dead space: space in a syringe where fluid is retained after the plunger has been depressed
i. considerations
1. mixing 2 drugs in 1 syringe (significant with volumes
Measuring dead space
i. draw up arbitrary amount of liquid
ii. remove air bubbles
iii. flush liquid by depressing plunger
iv. pull back on plunger to withdraw dead space volume into syringe barrel and measure volume
Describe the technique for handling dead space when mixing 2 drugs in 1 syringe
a. will get too much of first drug and not enough of second drug
i. even if needle is changed between draws (hub too much of first and hub too little of second)
b. draw proper dose of each drug into separate syringes; into a third syringe transfer each drug solution
i. extra dead space volume remains in the original needles and syringe hubs
