Q: Should IV immunoglobulin (IVIG) products be tracked by lot number?
A: The simple answer to this question is yes, but why is the subject of this IVIG FAQ. Most IVIG preparations are not simply one vial administered to each patient. As a matter of fact, most adult patients receive doses in excess of 40 g, and the largest vial size on the market is 20 g. This necessitates either serial infusion of multiple vials or combining several vials into a final container with the full dose for administration. In either situation, multiple vials and multiple lot numbers for vials will be used.
Keep in mind that because all IVIG products are derived from blood, there is a very tight chain of control over the lots as the product is made. Blood from as many as 10,000 donors could be used to make a single batch of IVIG, and screening the donor as well as polymerase chain reaction testing of the blood now are required steps in the process.
In the mid-1990s, there was a major recall of batches of IVIG from one manufacturer because it was determined that hepatitis C could be transmitted to patients through this product. To warn the patients who had received this product, it was important to know who received the affected lots. At that time, it was not common practice in the inpatient setting to track IVIG to the patient by lot number. Some hospitals handled IVIG through their blood banks, and they were more likely to have used lot-number tracking for IVIG, as they do for all blood products. Hospitals that purchased their IVIG through the pharmacy department might have been able to determine the lots they purchased but not really which patients received those specific lots. This issue was very serious because many more patients had to be warned and tested than necessary.
After this incident, all of the manufacturers of IVIG products employed numerous methods to prevent viral transmission, such as solvent detergent, caprylate, and nanofiltration. However, because new viruses form and old ones mutate, it is never 100% guaranteed that viral transmission will not be a problem in the future.
Besides these issues with viruses, there have been recalls of IVIG products, the most recent being recalls of Octagam (Octapharma) due to increasing reports of thromboembolism related to the product and of Gammagard Liquid (Baxter) related to increased reports of allergic reactions. In these situations, it is very important that the products be sequestered but also that they be tracked to patients who have received them.
Most adverse reactions related to IVIG occur during the infusion, but many others can be delayed in their onset and physicians and patients may not recognize that the reaction is related to IVIG. Renal failure, aseptic meningitis, and thromboembolic disorders are among the potentially delayed adverse events that may be caused by IVIG infusions.
As a standard practice for IVIG safety, it would be prudent for the patient to always know the brand of product that is being infused and that the physician record the brand in the patient’s chart. It is equally important that the pharmacy keep track of the lot numbers used to prepare the IVIG dose for that patient and store those records for potential future use. For ease of use, a bar-coded system could be employed but at least a manual log should be kept. One final word of advice is that the bar code on the box (ie, bulk packages contain more than one vial) is not always the same as the bar code on the vial, and the bar code on the vial is the one you want!
Dr Siegel reported a consulting agreement with CSL Behring.