Pharmacist Supervision is Critical for Proper Preparation of CLINIMIX Multi-Chamber Bags

Problem: CLINIMIX E (Baxter) is a parenteral nutrition multi-chamber bag with one chamber containing dextrose and calcium and the other chamber containing amino acids and electrolytes. A seal that separates the two chambers must be broken to mix the contents of both chambers together prior to dispensing. Intravenous fat emulsion and additional electrolytes may be added as necessary.

In a case reported to us last week, a physician ordered this product to be administered ‘’if the patient does not eat at least 50% of breakfast.” Two pharmacists confirmed that the patient had in fact eaten 50% of breakfast, but the charge nurse wanted to monitor the patient’s lunch intake and then decide whether Clinimix E should be started. The pharmacy did not dispense the product. After the pharmacy was closed, two charge nurses signed a bag of Clinimix E out of the pharmacy (per protocol). The next day, another nurse discovered that the container had been hung without breaking the seal between the chambers. Only the chamber containing amino acids and electrolytes had infused. Since the access port for the IV administration set on the Clinimix E bag led into the chamber with electrolytes and amino acids, the patient received a concentrated dose of amino acids and electrolytes, including 30 mEq of potassium chloride, and no dextrose or calcium. Fortunately, the patient’s metabolic profile collected on the morning the error was discovered revealed normal values of electrolytes, and no adverse effects were noted.

Safe Practice Recommendations: ISMP has steadfastly opposed allowing nonpharmacy staff access to the pharmacy, due to unfamiliarity with many items in a hospital pharmacy’s inventory. This unsafe practice contributed to the error. Such access is also openly opposed by The Joint Commission and the American Society of Health-System Pharmacists (ASHP). In hospitals without 24-hour pharmacy service, it is safest to provide access to a preapproved formulary of medications via emergency kits, automated dispensing cabinets (ADCs), or other means chosen with safety in mind. The formulary and processes for accessing it should be approved by a pharmacy and therapeutics committee. Limit the availability of medications, quantities, dosage forms/strengths, and container types of drugs. Nurses should seek assistance from an on-call pharmacist when necessary. Outsourcing order review when a pharmacist is not onsite is another option, but a mechanism to transport or dispense medications only available in the pharmacy must be provided to avoid nonpharmacy personnel from entering the pharmacy for needed drugs. Also avoid starting the first infusion of parenteral nutrition when the pharmacy is closed.

Clinimix E, Clinimix (a similar product without electrolytes), and similar FDA-approved parenteral nutrition products may reduce medication preparation errors by lowering the risk of compounding calculations and minimizing the number of preparation steps. However, ISMP has published previous reports where nurses or pharmacy staff have failed to activate or mix multi-chamber bags of parenteral nutrition solutions, heparin (formerly available), antibiotics (ADD-Vantage), and other products that require manipulation prior to administration. If Clinimix E or Clinimix is available in ADCs or other areas outside the pharmacy, ensure that auxiliary labels (e.g., Mix Prior to Administration) have been applied to the product over the port that will be spiked with tubing to remind staff to mix the two chambers before administration. The company provides educational resources on its website that illustrate the multi-chamber bag technology and offer step-by-step bag activation training.

ISMP contacted Baxter to relay the reporter’s recommendation that the exit port for the IV administration set be relocated to the Clinimix E chamber holding dextrose and calcium rather than amino acids and electrolytes, reasoning that, clinically, accidental administration of 10 % dextrose poses less of a threat to patients than concentrated electrolytes. However, the chamber sometimes contains higher dextrose concentrations, which could cause harm. Such a change would also be difficult for the company to undertake in the short run because production lines would need to be retooled. The company considered this recommendation but suggested potential safety advantages to the current multi-chamber bag design.

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^{Institute for Safe Medication Practices (ISMP). Pharmacist supervision is critical for proper preparation of Clinimix multi-chamber bags. ISMP Medication Safety Alert! Acute Care. 2010;15(21):2-3.}