Learning Objectives

Question 1

Quality Control is:

Answer 1

prospective and refers to processes that can be measured as the product is being produced

Question 2

Quality Assurance is:

Answer 2

focuses on the end product and involves the evaluation of the final preparation and the facility in which it is compounded

Question 3

Measure:

Answer 3

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

Question 4

Design of sterile compounding area:

Answer 4

1. ante-area (ISO 7)
2. positive pressure buffer area for non-hazardous (ISO 7)
3. negative pressure buffer area for hazardous (ISO 5)

Question 5

Daily monitoring

Answer 5

Temp
Airflow
Humidity
(light and sound)

Question 6

Primary and secondary controls require:

Answer 6

Re-certification at least every 6 months

Question 7

Primary:

Answer 7

HEPA filters, airflow patterns, particle counts

Question 8

Secondary

Answer 8

viable air sampling, nonviable (particle count, airflow, air exchanges per hour)

Question 9

Documentation of training must include:

Answer 9

completion of didactic instruction, written tests, completion of media fill test, gloved fingertip, and surface sampling

Question 10

Monitoring:

Answer 10

i. periodic surface sampling

ii. electronic air sampling every 6 months

Question 11

Describe the three simulation tests required for personnel who compound sterile preparations

Answer 11

a. media fill: simulates most complex preparation personnel would be expected to compound (like our final practical)
b. gloved fingertip test
c. surface sampling

Question 12

Cite the requirements for end-product testing

Answer 12

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

Question 13

Define hazardous drug

Answer 13

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

Question 14

Exposures and sources of hazardous drug

Answer 14

• Inhalation, dermal, ingestion, injection

- Vial surface, work surface, administration and waste handling, poor technique

Question 15

Explain environmental controls for compounding hazardous drugs

Answer 15

a. designate storage locations (ventilated, negative pressure)
b. distinct labels
c. designate preparation area separate from other areas

Question 16

Discuss the role of primary engineering controls in compounding hazardous drugs

Answer 16

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

Question 17

BSC Class II

Answer 17

• Most ideal
  1. open front, dependent on air barrier
  2. should be vented 100% outside

Question 18

BSC Class III

Answer 18

1. essentially isolators
2. gas-tight unit
3. maintained under negative pressure

Question 19

Compounding Aseptic Containment Isolators (CACI)

Answer 19

1. designed to isolate hazardous meds and prevent compounder from being exposed to airborne meds
2. unidirectional airflow and vented outside
3. cleaning: clean, rinse, disinfect, rinse, gaseous sterilization

Question 20

Define closed-system vial-transfer devices

Answer 20

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

Question 21

PPE must be used for

Answer 21

receiving, shelving, compounding, administration, spill cleaning, waste disposal, and handling of patient waste

Question 22

Gloves:

Answer 22

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

Question 23

Deactivation

Answer 23

render compound inert or inactive

i. oxidizer (sodium hypochlorite/bleach)

Question 24

Decontamination

Answer 24

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

Question 25

Spills

Answer 25

ii. spill >5mL, call environmental services iii. skin contact  wash for 20min iv. eye contact  wash for 15min

Question 26

Peds IV Meds - See Lecture Flash Cards

Answer 26

Peds IV Meds - See Lecture Flash Cards

Question 27

Identify the essential components of TPN orders and labels

Answer 27

All ingredients Everything in mg/kg Must include access (osmolarity, concerns with peripheral vs central)

Question 28

Factors that help stabilize lipid emulsions

Answer 28

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

Question 29

Factors that enhance Ca:P stability

Answer 29

i. gluconate >> CaCl2 ii. low Ca:P product 1. Ca(mEq/L) * P(mmol/L) * 1.8

Question 30

Estimate the osmolarity of a TPN

Answer 30

a. peripheral TPN limit of 900mOsm/L | b. central TPN limit of 1800-2000mOsm/L

Question 31

Describe the quality assurance measures employed for TPNs

Answer 31

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)

Question 32

Describe the typical outpatient and/or home infusion pharmacy

Answer 32

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

Question 33

See Home Infusion Lecture Flashcards

Answer 33

See Home Infusion Lecture Flashcards

Question 34

Elastomeric Infusion device (Eclipse)

Answer 34

1. range of sizes, minimal nursing labor, no programming errors, ideal for patient mobility, easy admin and disposal 2. add diluent first then drug volume second

Question 35

Vista Basic Pump and Acclaim Infusion Pump

Answer 35

1. stationary infusion device attached to a pole for large volumes 2. non-ambulatory

Question 36

iii. Cadd Infusion Pump

Answer 36

1. ambulatory lightweight pump

Question 37

Measure syringe dead space

Answer 37

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

Question 38

Measuring dead space

Answer 38

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

Question 39

Describe the technique for handling dead space when mixing 2 drugs in 1 syringe

Answer 39

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