Medication Storage: Maintaining the Cold Chain

Failure to follow storage recommendations of pharmaceutical products can lead to reduced potency and potentially, therapeutic failure.6 In addition, hundreds of thousands of medications are discarded each year because of improper storage conditions resulting in millions of dollars wasted.6,7 It is estimated that between 5% and 10% of pharmaceutical products require refrigeration.8 The “cold chain” is the process of maintaining appropriate temperatures for medications that require storage in the refrigerator or freezer across the spectrum, from the manufacturer to administration, to ensure medication integrity. Within the toolbox below are tips and resources to help maintain the “cold chain” for medications that require storage in the refrigerator or freezer.

Abbreviations: C = celsius; F = Fahrenheit.

Topic

Tips and Resources

Freezers and refrigerators: Use proper equipment to safely store medications. Commercial grade, frost-free, stand-alone units are usually recommended, to provide the most reliable and uniform temperatures.1,2 It is also a good idea to use outlets that will be powered by generators or have back up electrical supply options to prevent unnecessary loss of medications due to power outages or equipment failures.1

Temperatures and monitoring

Implement a temperature monitoring and recording policy that meets applicable state laws and accreditation standards.

Store medications at recommended temperatures based on product labeling.

See our chart, Medications Stored in the Refrigerator, for a list of meds requiring refrigeration.

  • Typical recommended refrigerated medication temperatures:1,4 36°F to 46°F (2°C to 8°C)
    • Consider setting the goal temp in the middle (e.g., 41°F [5°C]) to allow for maximal excursions within range.2
  • Typical recommended frozen medication temperatures:1 -13°F to +14°F (-25°C to -10°C)
    • Typical recommended frozen vaccine temperatures:1,9,10 -58°F to +5°F (-50°C to -15°C)

Use an electronic or manual temperature monitoring system in order to record and access temperatures when necessary.1

Minimize temperatures fluctuations

Use these tips to minimize fluctuations and keep temperatures in range:10

  • Keep full, plastic water bottles in the lower compartment and door shelves of the refrigerators.
    • Label them as "do not drink."
  • Keep frozen ice packs in freezer compartments.
  • Only open doors when necessary.
    • Avoid storing food and beverages within medication storage units.
  • Ensure doors close properly.

Medication placement

Consider storing sensitive products and/or vaccines in separate refrigerators or freezers.1

Avoid storing medications on the doors of refrigerators or freezers.1,4

Avoid overfilling or crowding as this can block airflow within the unit.1,2,4

Temperature excursions: Be prepared for situations when temperatures fall outside recommended ranges. This can happen for a variety of reasons (e.g., human error, equipment failure, power outage). Depending on the product, lot number and expiration date, time of exposure to temperatures outside of the recommended range, and actual temperature of exposure, some medications may be still be safe to administer while others will need to be discarded. Have a plan in place to respond efficiently to ensure safe medication use and patient care.

Separate affected medications

Label affected meds as “DO NOT USE” to ensure they are not dispensed or given until integrity can be determined.10

Store the affected medicines under recommended conditions, until integrity can be determined.10

  • Store in a bag or separate container, apart from other products in the storage unit.

Gather information

Refer to product labeling of affected medication(s) to look for guidance on temperature excursions.

If product labeling doesn’t clarify medication integrity, collect information to have available and contact manufacturers:10

  • Drug name, lot number, expiration date
  • Date and time of temperature excursion
  • Length of time medication was exposed to inappropriate temperatures
  • Room temperature where refrigerator or freezer is located
  • Current temperature inside the refrigerator or freezer
  • Minimum and maximum temperature inside refrigerator or freezer
  • Were there water bottles stored in the refrigerator?
  • Were there freezer packs stored in the freezer?

Know who to contact

Manufacturer contact information can be found in the product labeling or online.

During a natural disaster (e.g., blizzard, flood, hurricane), consider contacting your government agency.

  • FDA: 800-835-4709 or after hours 301-796-8240
  • Canadian Disaster Database Secretariat email: cdd-bdc@ps-sp.gc.ca

Compounded sterile prep (CSP) and nonsterile prep storage: Compounded products may require refrigeration. Storage conditions should be clearly indicated and followed to maintain product integrity until the assigned beyond-use date.

Storage and beyond-use dates

Be familiar with stability information, CSP risk levels for contamination (e.g., immediate-use, low-risk, medium-risk, high-risk preparations), and storage conditions (e.g., room temperature, refrigerated, frozen).

Use the following to determine appropriate beyond-use dates based on storage conditions:

See our CEs, Compounding: Sterile Compounding and USP <797>, and Compounding Topical Preparations and Oral Liquid Dosage Forms, for more on storage conditions and beyond-use dates with CSPs and compounded topicals and oral liquids.

Receiving cold chain meds Pharmacy employees involved in the receiving of medications must be properly trained on maintaining the cold chain.

Receiving and unpacking

Implement a policy to receive and unpack refrigerated and frozen meds.

Familiarize yourself with how these packages are labeled for quick identification.

Verify that medications arrive under appropriate storage conditions before unpacking and making meds available for patient care (e.g., ice packs, insulation).2

Promptly unpack and store these meds under proper conditions to minimize temperature excursions.2

Dispensing cold chain meds: Ensuring proper medication storage conditions extends beyond the walls of the pharmacy, including dispensing to floor or to individual patients.

Refrigeration after dispensing

Have systems in place to ensure meds that require refrigeration AFTER dispensing are handled appropriately.

  • For outpatient meds requiring refrigeration before and after dispensing, consider placing empty bags in the non-refrigerated pick-up area with a notation (e.g., color coding, stickers) that the medication is in the patient pick-up area of the refrigerator.
    • Use appropriate auxiliary labels (e.g., refrigerate, use-by date) to remind patients about proper storage at home.
  • For inpatient meds requiring refrigeration before and after dispensing, be sure meds are placed in refrigerators when delivered to the floors.
  • For meds requiring refrigeration only after dispensing (e.g., some antibiotic suspensions, topical benzoyl peroxide/erythromycin), label medications with appropriate auxiliary labels (e.g., refrigerate, use-by date).
  • See our technician tutorial, Keep it Cool: Storing Meds in the Fridge or Freezer, for more tips.

Room temperature after dispensing

Be familiar with medications that can be stored at room temperature after dispensing.

Shipping refrigerated medications

Consider placing items in plastic bags to protect packaging from condensation during shipping.

Use insulated packaging (e.g., styrofoam coolers, insulated envelopes) rated to maintain controlled temperatures for an appropriate time (e.g., 48 hours).5

Use ice bricks or frozen gel packs to ensure cool conditions. Additional packs may be needed during warmer months.

Consider express delivery to avoid shipping delays and potential for unnecessary waste.

Ensure shipping address is a physical address rather than a post office box to ensure timely transfer to appropriate storage.

Vaccines: Failure to store and handle vaccines properly may reduce vaccine potency, leading to an inadequate immune responses in patients and reduced protection against diseases.9

Storage and handling

Use these resources for quick links about available vaccines and storage guidance.

Temperatures

Store vaccines in the middle of the refrigerator or freezer, to minimize variations in temperature.10

Store refrigerated and frozen vaccines at recommended temperatures based on product labeling.

  • Typical recommended refrigerated vaccine temperatures:9,10 36°F to 46°F (2°C to 8°C)
  • Typical recommended frozen vaccine temperatures:9,10 -58°F to +5°F (-50°C to -15°C)

Stay up to date

Stay up to date on vaccine recommendations:

Transporting

Consider these best practices to ensure proper storage when vaccines are transported off-site (e.g., immunization clinics, satellite facilities).3

  • Use insulated coolers with ice packs.
  • Avoid placing vials or syringes directly on ice packs (e.g., keep them in original containers to provide separation).
  • Minimize the number of times the cooler is opened.
  • Use a log to document temperatures before, during, and after transport.

Traveling with medications that require refrigeration: Help patients understand storage requirements and travel rules when traveling with meds that require refrigeration.

Storage

Counsel patients on specific storage requirements for medications.

Refer to product labeling and/or contact manufacturers to inquire about temperature excursion stability.

Provide patient education:

Travel

Refer patients to the appropriate agency to clarify rules and ask questions:

Project Leader in preparation of this clinical resource (330909): Beth Bryant, Pharm.D., BCPS, Assistant Editor

References

  1. Ontario College of Pharmacists. Practice policies and guidelines: protecting the cold chain. Approved September 2012. http://www.ocpinfo.com/regulations-standards/policies-guidelines/cold-chain/. (Accessed June 28, 2017).
  2. PBA Health. How to store refrigerated products in your pharmacy. July 2014. https://www.pbahealth.com/how-to-store-refrigerated-products-in-your-pharmacy/. (Accessed June 28, 2017).
  3. Government of Canada. National vaccine storage and handling guidelines for immunization providers 2015. https://www.canada.ca/en/public-health/services/publications/healthy-living/national-vaccine-storage-handling-guidelines-immunization-providers-2015.html#a9c. (Accessed July 28, 2017).
  4. ICP. Storage of refrigerated medications. http://www.icppharm.com/News-Resources/Articles/Storage-of-Refrigerated-Medications.aspx. (Accessed June 28, 2017).
  5. Reliance Rx. Frequently asked questions. https://www.reliancerxsp.com/faq_pat.asp#p4. (Accessed July 28, 2017).
  6. Cohen V, Jellinek SP, Teperikidis L, et al. Room-temperature storage of medications labeled for refrigeration. Am J Health Syst Pharm 2007;64:1711-5.
  7. Welte M. USA Today. Vaccines ruined by poor refrigeration. December 2007. http://usatoday30.usatoday.com/news/health/2007-12-04-spoiled-vaccines_N.htm. (Accessed June 29, 2017).
  8. Pharmaceutical Commerce. Almost a third of newly approved drugs are cold chain products. January 13, 2015. http://pharmaceuticalcommerce.com/cold-chain-focus/almost-a-third-of-newly-approved-drugs-are-cold-chain-products/. (Accessed June 29, 2017).
  9. Centers for Disease Control and Prevention. Vaccine storage and handling toolkit. June 2016. https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf. (Accessed July 11, 2017).
  10. Government of Canada. Immunization and vaccines: page 9: Canadian immunization guide: part 1 – key immunization information. March 2017. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-1-key-immunization-information/page-9-storage-handling-immunizing-agents.html#p1c8a6. (Accessed July 11, 2017).

Cite this document as follows: Clinical Resource, Medication Storage: Maintaining the Cold Chain. Pharmacist’s Letter/Prescriber’s Letter. September 2017.

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