According to AABB Standards, except for normal saline, drugs or medications must not be added to blood or blood components unless the added substance has been approved be the FDA to be added, or records show it is safe to add the substance to blood and components. An e-network member asked if anyone had ever encountered a physician who ordered a solution other than normal saline to be added to blood or a blood component, and if so, which ones? If such a practice occurred, what documentation of safety was on file to justify the practice? Does anyone know which solutions (other than normal saline) are FDA-approved for addition to blood and components?

To which the following replies were received:

1. According to this member Normosol-R pH 7.4 (Abbott), is approved for mixing with blood products. At this institution it is used in the rapid infuser during liver transplants.

2. Morphine and Demerol are reported as having been added to blood for a patient who was using a controlled analgesic device during blood transfusion. [Transfusion, September 1993, Meeting Abstract Supplement S100]. This member did not think that these drugs were FDA-approved for addition to RBCs.

3. A member reported that her facility, which is a level I Trauma center, uses Plasmalyte as a diluent on occasion for trauma patients; stating that the FDA had approved the addition of Plasmalyte to blood and blood products. In fact, her institution 'provided proof' that the FDA has approved addition of Plasmalyte to blood to AABB inspectors during a past inspection.

4. An opinion that conflicts with replies #1 and #3 above was provided by a member who said that there have been no solutions (other than normal saline) approved by the FDA for mixing with blood. This member claims to have recently looked into this issue extensively. According to the member, there have been some abstracts published about certain medications that have been tested that the authors consider safe when administered in the same tubing with blood; however, there has been no FDA approval. There is an abstract from the last AABB meeting by a group in Canada describing studies they performed with some drugs. The anesthesiologists who work at the member's institution would like to allow concurrent administration of blood and the following medications: morphine or meperidine, heparin [with NaCl only], insulin, cefazolin. This member suspects that even though AABB accredited facilities have procedures that state only 0.9% saline can be administered concurrently with blood, on occasion in certain situations the use of other solutions occurs. In fact one of the anesthesiologists at this member's institution stated "it is frequent practice by anesthesiologists at other institutions to concurrently administer medications with a transfusion in perioperative patients." By concurrent administration he means that medication actually is in contact with the red cells in the tubing.

EDITOR'S NOTE: It would seem prudent to examine the product package insert for evidence of FDA approval to add a substance to a blood product. If FDA approval is not evident based on the product package insert, it would seem prudent to have documentation on file that the addition of a substance to a blood product is a 'safe' practice, before actually adding the substance to blood products that will be used for transfusion. If members have such package inserts and would FAX them to me at 323-226-5925, I will compile a list of 'approved' solutions, and share the list back with the membership.

Please FAX copies of the package inserts of substances approved to be added to blood products to Dr. Ira Shulman at 323-226-5925 (see responses in ADDENDA below).

And here is what the AABB has to say about this thorny issue in their publication Standards Source, Sept, 1999 on J 8.300!

(This was the answer provided in that document. Please consider signing up to receive additional insightful responses to life's challenges!)

J8.300 Addition of Drugs and Solutions

Question: With the exception of 0.9% sodium chloride, USP, drugs or medications shall not be added to blood or blood components unless:

Question: If a patient has a triple lumen catheter and blood is being administered through one port, is it acceptable to run other fluids or medications through the other ports?

Answer: Standard J8.300 limits the drugs or medications that can be administered with blood. It is desirable that blood be the only fluid administered through a catheter at one time. Hypotonicity of some solutions may result in hemolysis, and the presence of excess calcium in others may result in clotting. Further, red cells stored for some weeks in CPDA-1 acquire a storage lesion and lose some of the buffering capacity of fresh human blood, and are theoretically less able to cope with the injurious effects of some high- or low-level pH drug solutions.

In addition, when a solution is infused simultaneously with blood and there is an adverse event, it becomes difficult to distinguish whether the blood or the solution is the cause. In this case, the transfusion has to be interrupted and the unit potentially discarded. The use of another unit increases the cost of the therapy and exposure to multiple donors when another unit is selected.

There may be circumstances, however, when infusing separately is not practical. If simultaneous infusion is practiced within an institution, procedures should describe the circumstances under which infusing blood and solution simultaneously is acceptable and which solutions can be used in these circumstances. For example, Amphoteracin B and IL-2 are medications that frequently yield adverse reactions. In addition, the package labeling of medications and solutions should be examined for any contraindications for administration with blood components.

Typically, multi-lumen catheters have the exit holes for each lumen physically separated by a distance of approximately 2.5 cm and exit on different sides of the catheter. This design allows for dilution in the blood vessel and minimizes any mixing of infusing solutions. Thus, at slow rates of infusion, it is unlikely that the blood component exiting the catheter would be affected. Even under these circumstances, however, an adverse effect on the blood component cannot be excluded with all solutions. The risk of an adverse reaction should be weighed against the benefit of giving both fluids simultaneously.

Solutions that are not approved for simultaneous infusion include lactated Ringer's solution, 5% dextrose in water, and hypotonic sodium chloride solutions. Acceptable solutions for this practice include calcium-free isotonic electrolyte solutions that meet the requirements of the FDA and the Circular of Information for the Use of Human Blood and Blood Components. These solutions include ABO-compatible plasma, 5% albumin, or plasma protein fraction. All solutions are to be administered with the approval of the patient's physician.

For more information, see these issues of TRANSFUSION:

• 1975; 15: 250-255
• 1993; 33 (Suppl.): S100
• 1997; 37 (Suppl.): S333

ADDENDA Feb. 4, 2001

5. Editor's Comments: In response to my earlier request that members FAX copies of package inserts pertaining to acceptable non-plasma diluents for red cells for transfusion, a number were received and are shown below:

If there are other package inserts that specifically state an IV solution can be used in some way with blood components, please send me a FAX (323-226-5925) of the package insert, to share back with the e-Network.

ADDENDA June 4, 2006

6. Editor's note: The Editor wonders if any Intravenous Solutions (in addition to those listed above) have been approved for mixing or administration along with blood products.

ADDENDA April 15, 2007

7. A colleague in San Francisco reports that in addition to the electrolyte solutions already discussed above, 'Daily Med' states that Plasma-Lyte 148 may be administered with blood products. Specifically, the posted information states that PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP) is compatible with blood or blood components. It may be administered prior to or following the infusion of blood through the same administration set (i.e., as a priming solution), added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. PLASMA-LYTE 148 Injection and 0.9% Sodium Chloride Injection, USP are equally compatible with blood or blood components.

ADDENDA April 24, 2007

8. A transfusion service medical director in Oregon reports that the attached image illustrates the effect of mixing an incompatible solution with RBCs. Reportedly, the RBC unit was returned to the blood bank by an RN who inadvertantly added Mannitol Injection, USP into the unit through a Y-connector.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator