A freezer or refrigerator temperature excursion is really a never event. By investing a quality storage unit, and taking appropriate steps to prevent unplugging, there should be no reason why it happens. A good temperature monitoring device ensures accurate measurement and mimics the internal temperature of a bottle, rather than ambient air temperature.
In spite of this, it has happened to me four times in my career. Why is that? For me, it was because the companies owning the pharmacy I was managing did not invest in a medical refrigerator, so I was stuck handling temperature excursions until I threw away enough medicine they realized it costs less to buy a medical refrigerator.
I never intended to become an expert in vaccine storage and handling but because of these experiences (and my subsequent anxiety in the pharmacy about it happening again) I have spent more time with the CDC Vaccine Storage and Handling Toolkit than I care to admit.
Based on the CDC guidelines (found on page 35 of the toolkit), and taking into account practical tips I learned the hard way, here is your step-by-step guide to efficiently, and appropriately, handling a temperature excursion.
By the way, this is typically handled by the primary or alternate vaccine coordinator (it is a CDC guideline to have a coordinator who is an expert in this area) but in my opinion it is a best practice to have these steps clearly posted and staff at least familiar with how to respond. After all, it is possible a primary and alternate vaccine coordinator are not available.
The first step, though, in any temperature excursion is to attempt to notify one of the vaccine coordinators.
1. Record the present temperature, min and max, and length of time with possible exposure
This is determined from the temperature log data. If you have a Temperature Monitoring Device that is a Digital Data Logger (DDL) (you should), pull the data from the device to determine the exact amount of time spent out of range.
2. Label all medications and vaccines in the storage unit as “DO NOT USE" for right now
You want to be sure nothing in the refrigerator/freezer is dispensed or administered until you can validate its stability.
3. Inspect the unit and check its current temperature
If the storage unit is currently in range and appears to be functioning properly, proceed to the next step. If out of range or appears to have a maintenance problem, move medications to a backup storage unit and proceed to next step.
4. Take an inventory of all medications that were exposed
Next, you'll need to inventory everything in the refrigerator so that you know what has been exposed.
Be sure to list:
Drug name and NDC
Lot number and expiration date
Manufacturer
Whether or not this is the medication's first excursion (if the unit has been through a previous excursion)
IMPORTANT: while it's not necessarily required to be part of the documentation, if you do not write down the manufacturer, you will end up having to call the same medical affairs phone number multiple times as you miss items on the list.
It is much easier to record the manufacturer and only make one phone call per manufacturer, especially because hold times can be long.
5. Call the manufacturer for each exposed medication
Next up, you'll want to call the manufacturer. You need to call them to determine if there is any off-label stability data to support its continued use. In many cases, they have data to support its continued use, which saves you a lot of money from having to waste expensive inventory.
They'll ask you how long it was exposed, what temperature it was exposed to, and whether or not this was the first exposure.
Document the conversation and case number. It is extremely important to get the case number - how else can you prove you spoke to the manufacturer?
6. For medications without stability data to support continued use
For medications without any off-label stability data, you'll unfortunately have to dispose of them. Discard those in the expired/waste medication bin in accordance with you pharmacy's policy.
PRACTICE TIP: Some manufacturers might give full credit for doses that are expired, so it's worth getting in touch with their reps. I remember when some Zostavax went through an excursion once the Merck rep let me know we could get full credit (if they were in fact not stable) by waiting to give them to our reverse distributor until past their labeled expiration date. Talk about a lifesaver!
7. For medications with stability data to support continued use
They may be used until the date the manufacturer has provided. LABEL each medication as previously exposed; in the case of another excursion, the manufacturer will need to know it was not the first excursion.
Also, if the manufacturer gave you a date other than the labeled expiration date, clearly LABEL that on the package. Past the date they give you, the medication is not stable and is equivalent to giving a patient an expired medication or vaccine.
After the immediate problem is handled, the vaccine coordinator can contact an HVAC technician to troubleshoot why it went out of range, if necessary. One time it happened to me, for example (thankfully I had moved the meds to my backup unit because it was making me nervous), the thermostat was not working properly and causing wide temperature fluctuations. Ever since that part was replaced it's been working like a charm.
Resources for Action Plans and Documentation Forms
Because the Action Plan needs to be clearly communicated to staff, I recommend taping it on the refrigerator and/or freezer door. Having an extra copy of it in the Compliance Binder is not a bad idea either.
The CDC's action plan on page 35 of their toolkit is OK, but the problem is that there is a lot of text and it doesn't clearly lay out step-by-step rules for staff, which in my experience leads to a lot of variation in action (with anything). It also says "Contact your immunization program and/or vaccine manufacturer(s) for guidance per your standard operating procedures (SOPs)" but we need to specify those SOPs to be sure it is handled appropriately.
Immunize.org also offers an excursion tool, but again it does not clearly lay out what to do, does not have a section to inventory each item in the storage unit as well as associated info, and leaves too much up to individual staff interpretation.
I addressed some of the shortcomings of immunize.org's excursion tool with the Excursion Toolkit.
Here are some of its features:
1. Comes with an easy to use, step-by-step Action Plan that can be taped on the refrigerator/freezer (and contains the step-by-step guide in this post).
2. Has an inventory tool that will prompt staff to ask for all necessary information.
3. Has many of the most common refrigerated medications, and their NDCs and manufacturers, filled in to save you time writing (trust me - this part is a huge hassle, which is why I filled them in). There are plenty of blanks because you're most likely going to have things not filled in, but most of the work is done. For generics, the NDC and manufacturer are left blank so you can fill in the specific one you have.
To help you even more, I've also created label templates for the medications - one says "DO NOT USE UNTIL FURTHER NOTICE" and the other one "PREVIOUSLY EXPOSED" with a spot for the new Beyond Use Date.
Trust me they will save you a lot of time and keep you more organized compared with writing on the package with a Sharpie.
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