Discover the benefits, risks, and best practices of IVIG pooling based on INS and IgNS guidelines to ensure safe and effective patient care.
By Candy Finley, RN,IgCN, Clinical Nurse Educator II - February 14, 2025

Pooling Intravenous Immune Globulin (IVIG) has become a topic of discussion among healthcare professionals, especially in home infusion therapy (HIT). In the dynamic field of healthcare, particularly in HIT, the importance of adhering to established standards cannot be overstated. This blog will provide insights into pooling IVIG and describe advantages and disadvantages of pooling based on guidelines from the Infusion Nurses Society (INS) and the Immunoglobulin National Society (IgNS). By aligning our practices with these recognized standards, we can enhance patient safety, improve outcomes, and ensure the highest quality of care.

Understanding Pooling in Infusion Therapy

Pooling refers to the process of transferring multiple product sizes of a single brand of IVIG into an empty sterile intravenous bag prior to patient administration. For example, transferring one Gammaplex 20 gm vial plus one Gammaplex 10 gm vial plus one Gammaplex 5gm vial for one 35 gm dose. This practice of pooling must be conducted with caution, adhering strictly to aseptic technique and recognized guidelines to minimize risks associated with contamination. Pooling offers several benefits: ease of administration for the nurse, the ability of the patient to freely ambulate, and, if dropped, possibly a reduced risk of container breakage during administration. The disadvantages, however, include the risk of losing a large amount of product in the event of a break in container integrity, patient experiencing an unresolvable or intolerable adverse drug reaction (ADR), and losing intravenous access during administration. Also, when IVIG is pooled and an ADR occurs, if there are different lot numbers in the batch, isolation of the culprit lot would not be possible. Additionally, most payers will not pay for wasted replacement drug, leading to a missed dose or a patient having to pay out of pocket.

1. Adhering to the Standards of the Infusion Nurses Society (INS) provides comprehensive guidelines on infusion practices. Nurses should familiarize themselves with these standards, particularly the protocols for handling and administering pooled products.

According to Standard 56, when performing complex compounding preferentially it should be done in the pharmacy environment. Whenever possible, in the home, medications that require special attention during the compounding or preparation process should be supplied to the nurse in a ready to administer form. Additionally, according to the standard: such medications may include those requiring filtration during preparation, susceptible to microbial growth (e.g., lipids or dextrose), involving a complex calculation requiring dilution and those with long dissolution times, multistep procedures, or specialized reconstitution instructions. Avoiding unnecessary manipulation will decrease the risk of dosing errors and contamination.

2. Adhere to IgNS Immunoglobulin Therapy Standards of Practice.

IgNS Immune Globulin Therapy Standard of Practice 3.2 emphasizes the importance of evidence-based practice in the use of immunoglobulin. Their standards outline criteria for pooling, including use of sterile technique, proper product storage conditions, and monitoring and documentation of pooling activities. IgNS standards also include the US Pharmacopeia (USP) Compounding Standards that states pooling several vials of IVIG into a plastic bag is classified as using only one sterile product. Therefore, pooling IVIG within a home setting falls under the immediate-use compounded sterile product standard, provided that all relevant criteria set forth in the USP Chapter <797> compounding standards are met. This standard must be met by pooling/combining no more than 3 different sterile products (i.e., lot #’s) and that administration occurs within 4 hours of preparation. Nufactor’s standards of practice are followed by instructing all field nurse to first access the patient first PRIOR to accessing the product to ensure this practice is met. Once the infusion has started and for some reason the full dose cannot be administered the remaining product must be wasted and cannot be stored in the refrigerator for any length of time.

3. Risk Assessment

Prior to pooling, determine organizational policies on pooling. If allowed, conduct a thorough risk assessment. Evaluate the potential for contamination and weigh it against the benefits of administering pooled IVIG. This assessment should include an analysis of patient-specific factors, such as underlying health conditions, previous reactions to Ig products, and reliable IV access.

At Nufactor the preferred method of IVIG administration is via the sequential administration of vials starting with the smallest vial and working up to the largest vial. This practice ensures the least amount of drug is wasted in the event the patient experiences an ADR or loses IV access. Pooling is not the preferred method practice of infusion for Nufactor patients. Pooling must be discussed with pharmacy and approved prior to being put into practice.

4. Patient Education

Educating patients about the pooling process and its purpose is essential. Clear communication can alleviate anxiety and foster trust. Ensure that patients understand the benefits and potential risks associated with receiving pooled IVIG.

5. Documentation and Reporting

Maintain meticulous records of pooling activities. Documentation should include the lot number and expiration date of the IVIG, the pooling process, and any patient reactions. This information is vital for accountability and quality assurance.

Conclusion

Pooling IVIG is a complex procedure that requires a thorough understanding of the relevant guidelines from the INS and IgNS and benefits/risks. While it is safe to pool IVIG there is always a risk for adverse reactions and allergic reactions and potentially wasting drug. By adhering to standards, healthcare providers can ensure safe and effective therapy, ultimately leading to better patient outcomes. Continuous education, risk assessment, and quality control are essential components in maintaining the integrity of the pooling process. Always stay updated with the latest standards and engage in continuous professional development to deliver the best care possible.

References

• Infusion Nurses Society. (2024). Infusion Therapy Standards of Practice 9th Edition. Journal of Infusion Nursing.
• Immunoglobulin National Society. (2023). IgNS Immunoglobulin Therapy Standards of Practice Edition 3.2
• National Institutes of Health. (2019). Guidelines for the Preparation and Administration of Immunoglobulin. NIH Publication.