Labeling Refrigerated Medications

Wordle is a word game where the objective is to determine a five-letter word in six guesses. On average it takes four to solve the puzzle. Now, imagine you work in healthcare and the medication you just pulled out of the refrigerator has blurred, smudged or missing labels, all common issues with refrigerated drugs. Clinicians can’t afford four tries to get it right. Patient safety depends on instant certainty. 

Refrigerated medications shuttle to bedside through shifting temperatures and moisture which requires a label that can survive that journey intact. When they don’t, medication errors, wasted product, regulatory citations, and, ultimately, patient harm follow. The good news: labeling refrigerated medications properly stops the guessing game before it starts.

The Importance of Proper Labeling in Pharmacy and Clinical Environments

Whether a drug is compounded in the cleanroom, dispensed at the bedside, or stocked in an automated dispensing cabinet, its label is the primary communicator of identity, dose, route, storage conditions, and handling instructions. It’s why label material selection is so important. When medications require medications it adds a layer of complexity. 

If a label material is improperly spec’d and is applied to a medication that requires refrigeration at the CDC recommended  2 °C – 8 °C (36 °F – 46 °F) temperature range, it can cause the label to curl, detach, smear, fade and more. Without a label that contains the information medical professionals use to administer drugs properly, it elevates the potential for:

• Patient Safety Issues
• Accreditation Challenges
• Inventory Spoilage
• Increased Costs 

Unique Challenges with Refrigerated Medications

From the time a drug that requires refrigeration completes the manufacturing process and is distributed to a provider, it’s maintained through a cold chain system to ensure it remains within the designated temperature range. But, this cold chain creates challenges:

• Smudged or Blurred Type - Moisture caused from containers moving in and out of coolers, the shift from refrigeration to room temperatures can cause the printed medication information to smudge or blur.
• Label Wrinkling - Temperature fluctuations caused by the movement of drugs in and out of refrigeration stresses the bond between label, container and critical information.
• Label Detachment - Standard adhesives stiffen below 45 °F. This causes edges to lift or entire labels to detach from vials, syringes and other containers.

Compliance Implications and Patient-Safety Risks

The Joint Commission (TJC), the American Society of Health-System Pharmacists (ASHP) and the United States Pharmacopeia (USP) are just a few of the many organizations with standards that direct proper medication labeling. Even with these guidelines and the protocols organizations establish for their respective operations, medication labeling remains an area that is often cited for compliance violations.

In addition, medication errors rank as the most frequent and avoidable source of patient harm. Adverse drug events (ADEs) are among the most common and touch one in twenty in-patients, according to the Agency for Healthcare Research and Quality. A surprising share of those mishaps can be traced back to medication labeling issues. 

For medications that require refrigeration, improper material and adhesive selection is the most common cause of label failure. When a label detaches from a container or obscures vital information it puts patient outcomes at risk.

Not surprisingly, this can jeopardize patient outcomes. When containers for all solutions and medications don’t contain accurate and complete labeling the clinical staff is trained to throw them away. Yet, the National Institute of Health reports that sometimes those medications still get administered to the detriment of the patient. When the drug is disposed of in accordance with protocols, it eliminates the patient safety issues, but it still results in wasted time and wasted money.

The Risks of Improper Labeling in Cold Storage

Improper labeling in cold temperatures creates a number of risks.

Adhesive Failure

Lost instructions or drug identity. When a label detaches from a vial, syringe or container, clinicians lose instant access to all kinds of information including the drug name, strength, quantity, expiration date, and specific storage instructions.

Medication Errors

While unlabeled medications are typically discarded, those missing instruction labels might go undetected. In such cases, the medical team may be unaware that crucial information regarding intended uses, warnings, and directions is absent, elevating the risk of medication errors.

Regulatory Findings

TJC standard MM.03.01.01 - states “the organization safely stores medications,” and the pharmacy refrigerators and freezers are often the first place surveyors look.” Detached or illegible labels lead to corrective action plans and potential financial penalties.

Best Practices for Labeling Refrigerated Medications

Take these steps to ensure medications that require refrigeration remain labeled from storage through administration. 

1. Use Cold-Temperature Adhesive Labels

Look for labels engineered with specialty adhesives that perform given your specific conditions. These include: 

• Application Temperature - the temperature at the time the label is applied to the medication
• Service Temperature - the temperature range the label will be exposed to during use
• Type of Surface - refrigerated medications are typically held in glass or plastic containers, but cardboard and paper are also possibilities
• Additional Functionality - does the label need to wash off the surface or have an environmental requirement, such as compostability?

2. Ensure Legibility and Durability

Medications are exposed to a variety of conditions that impact label performance. In addition to selecting materials that fit your temperature range requirements, use materials that are durable and resistant to moisture, oil, and solvents. Plus, when adding variable information such as Beyond Use Dates (BUDs) or other notations, use a permanent marker or waterproof pen to prevent smudging. 

3. Include Clear Storage Instructions and Warnings

Color-coded auxiliary labels such as “REFRIGERATE,” “DO NOT FREEZE,” or time-sensitive BUD warnings - give clinicians instant visual cues. 

UAL stock medication labels are built with:

• Adhesives rated to perform down to –65 °F (–18 °C)
• Polypropylene materials that are durable, tear-proof, and resistant to moisture, oil, and solvents, making it suitable for cold storage environments.
• Custom label tools that enable healthcare organizations to create tailored solutions that ensure compliance and patient safety.

Regulatory Compliance and Patient Safety for Refrigerated Medications

Regulations covering refrigerated medications tend to be more general than specific. For example, the Joint Commission standard MM.03.01.01 EP 2 requires that medications are stored according to manufacturer's instructions for use. 

But whether they are refrigerated or not, the FDA does make these requirements:

• To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing.
• Expiration dates shall be related to any storage conditions stated on the labeling, as determined by stability studies.
• If the drug product is to be reconstituted at the time of dispensing, its labeling shall bear expiration information for both the reconstituted and unreconstituted drug products.

Clear, intact labeling that retains its integrity through the cold chain will help enhance patient safety and meet compliance requirements. 

Implementation Tips for Pharmacy Teams

To ensure refrigerated medications are labeled properly, pharmacy teams should:

• Select the Right Labels for Cold Storage - Choose labels specifically designed for refrigerated storage, taking into account factors such as adhesive strength, durability, and legibility.
• Test in Real Conditions – Apply sample labels to actual drug containers and the conditions they will be exposed to.
• Test if changes occur with Vial, Test Tube or Syringe suppliers - What appears to be the same item may contain different materials that impact the performance of a label that worked previously. If a supplier change does occur, test the label performance to avoid issues.
• When Variable Information is Required - Use permanent or waterproof markers when adding in BUDs or other variable information to prevent it from becoming illegible.
• Educate Staff - on refrigerated medication protocols and proper labeling procedures.

Partnering with UAL for Refrigerated Medication Labeling

With over 60 years of experience producing labels for cold temperature applications, United Ad Label is a trusted partner for healthcare organizations. Contact us to learn more.