Cold Chain Storage Requirements. What you need to know for the NAPLEX and MPJE exams

COLD CHAIN STORAGE REQUIREMENTS. WHAT YOU NEED TO KNOW FOR THE NAPLEX AND MPJE EXAMS

Cold Chain Storage Requirements 

In your pharmacy career it is almost guaranteed that you will handle medications with special storage requirements, thus these storage requirements are addressed on the NAPLEX and MPJE. This article provides guidance on the minimum requirements you need to know as a pharmacist.

Introduction to Storage Requirements

When drugs come to market, companies provide storage requirement information to ensure the medication is not compromised before it reaches the patient. The storage requirements for drugs are determined by the available stability data from clinical trials run by the manufacturer. Because the manufacturer cannot guarantee the integrity of the drug outside these storage parameters, drugs must be stored according to the manufacturer’s label. 

In clinical practice, as drugs are on the market for longer periods of time, you may be able to obtain off-label stability studies if you think a drug’s integrity has been compromised. These off label studies should only be used in extenuating circumstances, such as if a patient left his/her drug in incorrect storage conditions for any period of time. 

Storage of Commercially Available Products 

The refrigerator in the pharmacy used to store drugs carries certain requirements, including: 

1. The refrigerator must be used exclusively for the storage of prescription drugs 

2. The temperature must be continually monitored and logged regularly

3. If the temperature falls out of range, an alert system must signal to the pharmacist so that this can be corrected immediately.

In practice, you can find storage information on the label of the drugs. Many medications require refrigeration when kept at the pharmacy, but can be kept at room temperature when dispensed to the patient. These medications are shipped to the pharmacy from a wholesaler in refrigerated totes and should be placed immediately in the pharmacy refrigerator upon receiving. If your pharmacy mails or delivers medications to patients, these medications should be mailed or delivered in a refrigerated bag, even though the patient themselves may store the drug at room temperature. This practice ensures that the medication will not be compromised before it reaches the patient. In the event that delivery fails, it also ensures that the medication was kept at proper storage conditions, and delivery can be reattempted or the drug can be returned to stock without consequence. 

On the other hand, there are medications like antibiotics that are mixed with water and require refrigeration when given to the patient. These are shipped from the wholesaler in a room temperature tote, but when given to the patient should be refrigerated. To ensure medication safety and effectiveness, always pay attention to these labels! If your pharmacy mails or delivers medications to patients, these medications can be risky to deliver. To ensure proper mixing, it is best practice to mix these medications at the pharmacy and deliver them to the patient in a refrigerated tote. In special cases, you may consider measuring the proper mixing amount of liquid into a separate bottle so the patient can mix themselves. 

Storage of Compounded Products 

Memorize the following for the NAPLEX or MPJE. There is a high probability you will have questions about these competency areas:

Low-risk compounds are those that are compounded with aseptic manipulations with only sterile ingredients. These compounds are those using sterile needles and syringes to transfer sterile liquids sealed ampules/vials to other sterile packages. An example would be reconstituting a vial of cefazolin and transferring to a syringe. The storage recommendations are as follows: 

• 48 hours at room temperature

• 14 days refrigerated

• 45 days frozen 

Medium-risk compounds are those that require multiple injections or attachments to a final sterile container. An example would be compounding total parenteral nutrition for a patient. The storage recommendations are as follows: 

• 30 hours at room temperature

• 9 days refrigerated

• 45 days frozen 

High-risk compounds are those that involve non-sterile components, making the risk of contamination very high. An example would be compounding an epidural from non-sterile powder ingredients. The storage recommendations are as follows: 

• 24 hours at room temperature 

• 3 days refrigerated

• 45 days frozen 

Conclusion 

Proper storage of medication ensures medication efficacy for patients, reduces harm to patients, and saves money in the health care system. For the NAPLEX and MPJE, it will be most important to focus on the requirements for the pharmacy refrigerator and the storage requirements for low, medium, and high-risk compounds. In practice, however, it will be most important to pay attention to the storage of drugs in your pharmacy and ensure you properly instruct patients on this storage. 

NAPLEX or MPJE Practice questions: 

Question 1: A multidose vial of Herceptin (trastuzumab) is used to prepare IV admixtures for 4 patients on the oncology floor of a hospital. What is the risk level for the admixtures? 

• A. High-risk 

• B. Medium-risk 

• C. Low-risk 

• D. Immediate Use

Question 2: A multidose vial of Herceptin (trastuzumab) is used to prepare IV admixtures for 4 patients on the oncology floor of a hospital. Which of the following is an acceptable storage requirement for the admixtures? (SELECT ALL THAT APPLY)

• A. 48 hours room temperature

• B. 30 hours room temperature

• C. 9 days refrigerated 

• D. 45 days frozen 

Question 3: If a medication requires refrigeration it should be stored in what temperature range? 

• A. 32⁰F and 48⁰F

• B. 30⁰F and 46⁰F

• C. 40⁰F and 50⁰F

• D. 35⁰F and 46⁰F

Answers for the NAPLEX/MPJE style questions listed above:

1. B

2. B, C, D

3. D

Taking practice MPJE®/NAPLEX® exams is key to passing the board exams on the first try. Practice exams:

1.   Expose you to time constraints and help you build mental stamina

2.   Expose you to different questions (K-type, select all, etc.)

3.   Expose you to random topics with various difficulties

4.   Expose you to new answer choices

5.   Help demystify the exams and ease test anxiety

PassRXnow offers MPJE practice content for 15+ states and 600+ NAPLEX questions covering clinical, patient profile, calculations, and top 200 generics/brand name drugs. All NAPLEX and MPJE practice exams have answers, explanations, and references. 1000’s of questions, all updated frequently. 

You can avoid the impact of failing the NAPLEX / MPJE by doing more practice exams. Check out our offerings. For transparency, you can see the last update date for each course at the top of the course page in the links below. Content is updated regularly.

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New states are constantly added. Click here to see the latest MPJE for all states.

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About the author

Tara Airola is a recent PharmD graduate from the University of Wisconsin-Madison School of Pharmacy. She currently works at a dermatology-specialized pharmacy in Chicago, IL. Her areas of interest include autoimmune diseases, cancers, and acne treatments.