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4 Top Vaccine Storage Misses
Vaccine temperature excursions can render the products unusable--and leave your practice with the tab. Here are 4 storage errors to avoid.
The Centers for Disease Control has since developed the Vaccine and Storage Handling Toolkit1which sets guidelines on maintaining the cold chain from manufacture to administration.
The short slide show above is based on my experience working with clinical offices and pharmacies and describes 4 top vaccine storage misses to be on the lookout for.
Miss #1. Inappropriate refrigerator selection. There are many important differences between consumer-model and medical-grade refrigerators. A primary difference is that the medical refrigerators are equipped to ensure temperature consistency within the cabinet. They also have safety features such as "door ajar" alarms and go through defrost cycles that minimize fluctuations in temperature.
Worth its Weight in Gold. Resistance to purchase of a medical-grade refrigerator is often the result of ignorance of the important differences, and the cost of the unit. However, that cost may be dwarfed by the price tag of a temperture excursion. Example: I worked for one company where we had 2 excursions while using consumer-grade models. Total cost to the company: >$25,000.
Miss #2. Inappropriate selection & replacement of temperature monitoring device. TMDs should be: Digital Data Loggers: A TMD tracks and logs temperatures 24- hours-a-day. Replaced when they expire: And they do expire. Calibration and traceability is not valid forever. Check the sticker on the wire of the device for an expiration date, and mark it on a calendar.
Miss #2. Inappropriate selection & replacement TMD. TMDs should be: Equipped with a probe suspended in fluid: This ensures the thermometer is estimating the vial’s internal temperature, not the temperature of the surrounding air. Equipped with an alarm that is set: By setting the alarm to go off when the temperature is either <36°F or >46°F, excursions can be discovered more quickly.
Miss #3 Documentation by office staff. Temperature monitoring by staff should be done/recorded twice a day. This is in addtion to the TMD data being recorded. The CDC provides a Best Practices infographic you can print out and post next to the temperature log.
Miss #4. Mishandling temperature excursions. Handling an excursion is more than adjusting the refrigerator temperature and checking in later. It's a reason to worry: once a vaccine is exposed to temperatures outside the range set by the manufacturer, the company will no longer guarantee its potency. Example: When aluminum-containing vaccines are exposed to freezing temperatures the aluminum clumps together, reducing efficacy.2,3
How to manage a temperature excursion:
- Get the medications back in range
- Download TMD data to determine how long temperature has been out of range
- Write down information on every product in the refrigerator. Include manufacturer, lot number, NDC number, and expiration date.
How to manage a temperature excursion:
- Call the manufacturers: Medical Affairs will give you any information they have on off-label data to support use after excursions.
- Document the phone call: Record the name of the person you spoke with and ask for case numbers.
How to manage a temperature excursion:
Label the vaccines: All vaccines that have gone through an excursion and have off-label data to support their continued use need to be marked as such.
Do you have an excursion near miss or success story you can share with Patient Care? Please send it to editor@patientcareonline.com
References
1. CDC Vaccine Storage and Handling Toolkit. Centers for Disease Control. Accessed online July 16, 2019 at https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf.
2. Kumru O, Joshi S, Smith D, Middaugh CR, Prusik T, Volkin D. Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies. Biologicals. 2014;42:237e259.
3. Clapp T, Siebert, Chen D, Jones Braun L. Vaccines with aluminum containing adjuvants: optimizing vaccine efficacy and thermal stability. J Pharm Sci. 2011;100:388–401.
A survey of Vaccines for Children program providers in 2012 revealed that over a 2-week survey period “vaccines stored by 76% of 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulaive hours during that period.” Images in the report taken during the survey show vaccines that had been exposed to freezing temperatures, some with ice visible on the box. (continued below).
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