Vaccine Storage + Handling Flashcards
Why can biologics lose potency + effectiveness over time?
due to denaturation (breakage of H bonds of protein structure) or deterioration
T or F: only high temperatures can impact biologics not low Temps
F- both can impact potency of biologics
T or F: appearance of solution is a relied indicator of potency + effectiveness
F - products with changes in appearance shouldn’t be used but just because there is no change —— doesn’t mean good to use
What temp should vaccines be stored at
bw +2 to 8: ideally 4-5 + protected from light
What is the cold chain
process used to maintain optimal conditions during all stages of handing (manufacturer—- distributor—- vaccine depot —- pharm —- client)
- breaches/failures: can occur at any stages
What does the consequence of breaches depend on
product and severity of breach
possible consequences of breaches in cold chain
-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
T or F: all team members that come in contact with items in cold chain need to know about requirements
T - this includes those in shipping + receiving areas + those doing med deliveries
T or F: each practice site needs to just have a primary vaccine coordinator that is required to always be present + know about CC
F - need a primary vaccine coordinator + backup individual
- every staff member needs to know who these people are
Layers (in order) of insulated container used to transport products
Bottom to top:
insulated container
ice pack
fridge temp ice blanket
vaccine
temp monitor
fridge temp ice blanket
ice pack
What needs to be labelled on each container used to transport product
Vaccine type
Lot #
quantity
date
time
originating facility
label saying contents fragile + temp sensitive
What needs to be documented during transportation
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 #
T or F: record keeping is an ongoing process at pharm when it comes to vaccines
T
Maintain tally sheet of the number of doses used (admin, wasted, spoiled, expired) + balance remaining in doses
How much month supply should the pharmacy have at 1 time
1 mth supply
T or F: Multi-use vials need to be marked with date of 1st puncture
T
T or F: vaccine fridge must be able to hold 5 mths supply worth of vaccines at one time
F- must be large enough to hold the year’s highest monthly inventory (most used within 1 mth)
T or F: each compartment of fridge needs to be monitored by a calibrated thermometer or data logger
T
T or F: the fridge holding vaccines can also hold drinks
F: not allowed in order to minimize temp fluctuations due to warm containers or frequent door opening
How do you restock the fridge when you get new products?
put the product with the earlier expiry date near the front
How do you ensure proper air circulation in the fridge
keep space bw each individual package + space on the sides + back of fridge
max of 50% used of fridge space
No more than ____ of the space should be filled with vaccines
50%
What should be place on any empty shelves and on any of the shelves of the fridge door?
Full water bottles: insulating effect
Can you store vaccines on the shelves on the door of the fridge
nope
What temperatures does the thermometer have to measure ?
current temp + max and min temp since last reset
Where should the thermometer be placed in the fridge
center ; could place sensor in an actual empty vaccine bottle to better estimate actual temp experienced by vaccine
How often should you check thermometer batteries?
every 6 mths
Requirements for documentation of fridge temp
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)
T or F: if there is breach that impact publicly funded vaccines, only the vaccine coordinator needs to be notified
F- must also notify PH
What needs to be recorded when a breach occurs
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
What should be done with the affected products after breach
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
