Vaccine Storage + Handling

Question 1

Why can biologics lose potency + effectiveness over time?

Answer 1

due to denaturation (breakage of H bonds of protein structure) or deterioration

Question 2

T or F: only high temperatures can impact biologics not low Temps

Answer 2

F- both can impact potency of biologics

Question 3

T or F: appearance of solution is a relied indicator of potency + effectiveness

Answer 3

F - products with changes in appearance shouldn’t be used but just because there is no change —— doesn’t mean good to use

Question 4

What temp should vaccines be stored at

Answer 4

bw +2 to 8: ideally 4-5 + protected from light

Question 5

What is the cold chain

Answer 5

process used to maintain optimal conditions during all stages of handing (manufacturer—- distributor—- vaccine depot —- pharm —- client)

• breaches/failures: can occur at any stages

Question 6

What does the consequence of breaches depend on

Answer 6

product and severity of breach

Question 7

possible consequences of breaches in cold chain

Answer 7

-re-immunization of patient (or booster) if worried about effectiveness
- cancellation of appointment if vaccine no longer useable
- wastage+ increase cost
- ability of vaccine provider to give vaccines

Question 8

T or F: all team members that come in contact with items in cold chain need to know about requirements

Answer 8

T - this includes those in shipping + receiving areas + those doing med deliveries

Question 9

T or F: each practice site needs to just have a primary vaccine coordinator that is required to always be present + know about CC

Answer 9

F - need a primary vaccine coordinator + backup individual
- every staff member needs to know who these people are

Question 10

Layers (in order) of insulated container used to transport products

Answer 10

Bottom to top:

insulated container
ice pack
fridge temp ice blanket
vaccine
temp monitor
fridge temp ice blanket
ice pack

Question 11

What needs to be labelled on each container used to transport product

Answer 11

Vaccine type
Lot #
quantity
date
time
originating facility
label saying contents fragile + temp sensitive

Question 12

What needs to be documented during transportation

Answer 12

date of arrival
name of person unpacking + checking shipment
condition of shipment

For each vaccine: the manufacturer, lot #, expiry, quantity of units received per lot #

Question 13

T or F: record keeping is an ongoing process at pharm when it comes to vaccines

Answer 13

T

Maintain tally sheet of the number of doses used (admin, wasted, spoiled, expired) + balance remaining in doses

Question 14

How much month supply should the pharmacy have at 1 time

Answer 14

1 mth supply

Question 15

T or F: Multi-use vials need to be marked with date of 1st puncture

Answer 15

T

Question 16

T or F: vaccine fridge must be able to hold 5 mths supply worth of vaccines at one time

Answer 16

F- must be large enough to hold the year’s highest monthly inventory (most used within 1 mth)

Question 17

T or F: each compartment of fridge needs to be monitored by a calibrated thermometer or data logger

Answer 17

T

Question 18

T or F: the fridge holding vaccines can also hold drinks

Answer 18

F: not allowed in order to minimize temp fluctuations due to warm containers or frequent door opening

Question 19

How do you restock the fridge when you get new products?

Answer 19

put the product with the earlier expiry date near the front

Question 20

How do you ensure proper air circulation in the fridge

Answer 20

keep space bw each individual package + space on the sides + back of fridge

max of 50% used of fridge space

Question 21

No more than ____ of the space should be filled with vaccines

Answer 21

50%

Question 22

What should be place on any empty shelves and on any of the shelves of the fridge door?

Answer 22

Full water bottles: insulating effect

Question 23

Can you store vaccines on the shelves on the door of the fridge

Answer 23

nope

Question 24

What temperatures does the thermometer have to measure ?

Answer 24

current temp + max and min temp since last reset

Question 25

Where should the thermometer be placed in the fridge

Answer 25

center ; could place sensor in an actual empty vaccine bottle to better estimate actual temp experienced by vaccine

Question 26

How often should you check thermometer batteries?

Answer 26

every 6 mths

Question 27

Requirements for documentation of fridge temp

Answer 27

must check min and max temp at least BID

• reset after each reading + record on temp log sheet (date, time, temps, and who did reading)

Question 28

T or F: if there is breach that impact publicly funded vaccines, only the vaccine coordinator needs to be notified

Answer 28

F- must also notify PH

Question 29

What needs to be recorded when a breach occurs

Answer 29

date + time

current fridge temp

Min and max readings

length of time vaccine may have been exposed to breach conditions

how fridge is set up

any actions taken to protect vaccines

any actions taken to correct breach

vaccine information: name, lot #, expiry, quantity affected

Question 30

What should be done with the affected products after breach

Answer 30

Clearly mark: do not use
- store in appropriate conditions (may need to transfer to fridge or insulated container in case they are still deemed useable later

— determine integrity of vaccine
- contact PH and manufacturer