The Importance of Correct Omegaven Storage
Omegaven, a fish oil-based intravenous lipid emulsion, is a critical component of parenteral nutrition (PN) for certain patient populations, particularly neonates with parenteral nutrition-associated cholestasis. Its effectiveness and safety are highly dependent on its physical stability. As an emulsion, it is a delicate mixture of oil and water, and improper storage temperatures can cause the emulsion to break down. This breakdown can lead to the separation of the oil and water phases, potentially forming large oil droplets that are unsafe for injection and could cause serious complications, such as pulmonary emboli. Therefore, understanding the precise storage and handling guidelines for Omegaven is not just recommended, but essential for patient safety.
Storing the Original, Unopened Omegaven Vial
The most important distinction in Omegaven storage is whether the medication is still in its original, sealed glass bottle or has been prepared into a parenteral nutrition admixture. For the original, unopened vial, manufacturers provide clear instructions.
- Store below 25°C (77°F): The medication should be kept at or below room temperature. Excessive heat should be avoided, as it can compromise the stability of the emulsion.
- Do not refrigerate or freeze: While the initial question of should Omegaven be refrigerated? might seem like a simple yes or no, the answer for the original vial is no. Refrigerating the original vial is not necessary, but more critically, freezing is strictly forbidden. If Omegaven is accidentally frozen, it must be discarded, even if it appears normal after thawing.
- Keep in original packaging: The vial should be kept in its carton until use to protect it from light.
Storing Compounded Parenteral Nutrition (PN) Admixtures
In clinical practice, Omegaven is often added to a larger PN admixture containing dextrose, amino acids, and other components. Once Omegaven is mixed with other solutions, the storage rules change dramatically due to altered stability characteristics and microbiological considerations.
- Immediate use is preferred: The prescribing information and guidelines from manufacturers and regulatory bodies generally state that infusions of admixtures containing Omegaven should be started immediately after preparation.
- Short-term storage under refrigeration is permitted: If immediate use is not possible, the admixture can be stored for a limited time under specific conditions. Admixtures may be stored for up to 6 hours at room temperature (below 25°C) or up to 24 hours under refrigeration (2°C to 8°C).
- Infusion time limits: Regardless of where it was stored, the infusion of the admixture must be completed within 24 hours of its removal from refrigeration. This strict timeline includes the entire period from mixing to final administration.
Crucial Safety Precautions
Handling intravenous lipid emulsions like Omegaven requires careful attention to detail to ensure safety and efficacy. Following these precautions is vital:
- Discard partially used containers: Omegaven is supplied in single-dose bottles with no preservatives. Any remaining contents from a partly used bottle or PN container must be discarded.
- Perform a visual inspection: Before administering any Omegaven or PN admixture, it is essential to visually inspect the solution. If the emulsion has separated or discolored (e.g., yellowish streaking or droplets), it must be discarded immediately.
- Follow proper mixing sequence: When compounding a PN admixture, the proper mixing sequence is critical to prevent pH-related instability. Dextrose is added first, then amino acids, and finally Omegaven.
- Infuse with control: When using a Y-connector to infuse Omegaven concurrently with other solutions, each flow rate should be separately controlled by an infusion pump.
Omegaven Storage Comparison: Original Vial vs. PN Admixture
| Storage Aspect | Original Omegaven Vial | Compounded PN Admixture with Omegaven |
|---|---|---|
| Temperature | Room temperature (below 25°C) | Refrigerated (2-8°C) or room temperature (max 6 hours) |
| Freezing | Not permitted | Not applicable (discarded before freezing) |
| Usage Window | Immediately upon connecting to infusion set | Up to 24 hours under refrigeration or 6 hours at room temperature |
| Infusion Completion | Within 12 hours of connecting infusion set | Within 24 hours of removal from refrigeration |
| Container | Original sealed glass bottle | Sterile PN bag or syringe |
| Condition | Unopened, sealed | Prepared under aseptic conditions |
Conclusion
The question of whether should Omegaven be refrigerated? has a nuanced answer that depends on the medication's form. The original, sealed Omegaven vial should be stored at room temperature, but never frozen. Conversely, once Omegaven is incorporated into a compounded parenteral nutrition admixture, it can and should be refrigerated if not used immediately, for a maximum of 24 hours. Given the potential for harm from improperly handled lipid emulsions, healthcare providers must meticulously follow these storage, handling, and administration protocols to ensure patient safety. For comprehensive details, always consult the most current product information from the manufacturer and regulatory bodies.
To learn more, see the official prescribing information on Drugs.com.
