Storage of Refrigerated Medications

As seen in the Consultant Connection November 2014 Issue
Angie MeClenathan, B.S., CPhT., ICP Consulting Pharmacy Technician
IIt is important to understand the guidelines and proper storage of refrigerated medications. All medication temperature requirements can be found in the manufacturer’s package insert or directly on the container’s label. If unavailable through the package insert or labeling, storage conditions can be obtained by calling the manufacturer directly or via their website.
The “cold chain” is a system of maintaining the stability and viability of a medication while in transit from the manufacturer to the patient.1 This cold chain starts at the manufacturing plant then goes to the distributor, to the provider facility and finally to the patient. Any break in the cold chain could result in the instability and loss of efficacy of the product. Excessive heat, cold, moisture and light are elements that can cause possible damage to the product and decrease the products efficacy. Some medications may visibly show a compromised medication through cloudiness and/or clumping. However, other medications may not show any signs of alteration, thereby leaving the impression the medications are fine.
It is the provider’s responsibility to maintain proper storage and to monitor the temperature on a regular basis. The temperature parameter for refrigerated medication is 36-46 degrees Fahrenheit. Refrigerated medications should be positioned within the unit in such a way to allow proper air flow and not allow temperature fluctuations. The National Institute of Standards and Technology (NIST) conducted a study to determine the best practice for storage and temperature control of refrigerated vaccines.2 This study helps to explain the positioning, types of thermometers and types of refrigerators used for vaccine storage. This information can be extrapolated to include all refrigerated medication control.  Medication being stored in the door shelves, on the refrigerator floor or directly against the wall of the refrigerator could result in fluctuations in temperature. Medications should remain in the original package and be stored in the center of the refrigerator for optimal temperature control. Keeping a working thermometer in both the refrigerator and freezer and maintaining a daily temperature log will also help to guarantee the cold chain. Thermometers should be placed next to the medication in the refrigerator.
Knowledge of the temperature guidelines and proper storage of refrigerated medications ensures the viability of the medication upon dispensing. Another important responsibility of the provider is establishing an emergency protocol in case of power failure, fire or any other type of natural disaster. This emergency protocol should be updated annually.
The last step in the cold chain is the patient. It is important to give proper patient education. The patient needs to understand the temperature guidelines of their temperature specific medications and the possibility of decreased efficacy of the medication by not following proper storage conditions. Their disease state/treatment will be affected if the medication efficacy is not ensured. Talking to the patient about where/how they are storing the medication will help diminish an issue with temperature instability. Insulin can be kept at room temperature to make an injection more comfortable for the patient. Any insulin stored outside the refrigerator is subject to the manufacture’s expiration guidelines for being stored outside the refrigerator.
The best way of ensuring the efficacy of the medication is by following the temperature guidelines set by the manufacturer and documenting the maintenance of that temperature.3 Not ensuring the proper temperature could result in a damaged product, increase costs to both consumer and supplier, repeat administration of the medication due to decreased efficacy, provider liability and damage to the reputation of the facility
1. Rogers B, Dennison K, Adepoju N, et al. Vaccine cold chain: Part 2. Training personnel and program management. AAOHN J. 2010;58(9):391-400
2. Chojnacky M, Miller W, Strouse G. thermal Analysis of Refrigeration systems Used for Vaccine Storage: Report on Pharmaceutical Grade Refrigerator and Household Refrigerator/Freezer. Sept 2010.
3. Konrad W. Mistakes in Storage May Alter Medication. The New York Times. August 15, 2011. 

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