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Infant's death reinforces need for medications to be dispensed in ready-to-use form

From the September 9, 1998 issue

PROBLEM: In a neonatal intensive care unit (NICU), a 7.4 mg loading dose of aminophylline was ordered for a premature infant with episodes of apnea. Instead of 7.4 mg (0.3 mL of a 250 mg/10 mL solution), 7.4 mL (185 mg) was administered to the baby girl. Her theophylline level was markedly elevated and the infant developed tachycardia and other significant signs of theophylline toxicity. Her condition deteriorated and she soon required intubation and ventilator support. Despite these and other measures, the infant expired within 36 hours of the incident. According to newspaper reports last week, aminophylline was available as a floor stock item and was prepared by the nurse who gave it, without an independent check by a second individual.

SAFE PRACTICE RECOMMENDATION: Current JC standards require "medications to be dispensed in the most ready-to-administer form possible to minimize opportunities for error" (TX.3.5 through TX.3.5.2 in the Comprehensive Accreditation Manual for Hospitals). It is reasonable to interpret this standard to mean that when commercial unit dose products are not available, having the hospital pharmacy department prepare and dispense non-emergency parenteral doses should maximize safety. In this way, internal pharmacy quality assurance mechanisms, as well as pharmacist-nurse check systems can be utilized to reduce error potential. This process is important in the care of neonates, especially with "high alert" drugs such as aminophylline, where the consequences of errors are great and even minor dose miscalculations could prove disastrous. Despite the JC standard, in many hospitals where ISMP evaluated medication systems, we found NICU nurses solely responsible for reconstituting or diluting parenteral doses taken from floor stock. Worse, this is often done in the absence of a policy stating that medications prepared for neonates must be independently checked by at least two individuals to assure the order has been properly interpreted, that the correct medication has been used, and that dosage calculation, preparation, and labeling is accurate. We are asking hospital accreditation agencies, state departments of health and state boards to focus greater attention on this issue. Just asking if a unit dose system exists is not enough. Medications and methods of administration available to NICU patients today have dramatically improved outcomes. However, it's a double-edged sword. Some hospitals, in their quest to minimize costs, have not responded by ensuring that adequate systems and staff are in place to promote safe use of the new medications and delivery techniques. We strongly urge high-level hospital administrators to thoroughly examine medication practices in their own NICU.

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