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In utero medication administration to fetus presents unique safety challenges

July 11, 2013
Certain procedures performed in utero may require administering medications directly to the fetus. Typically, in a perinatal setting, the unborn baby is not yet registered as a patient and does not have an active medical record. Because an alternative does not exist, medications intended for the unborn baby are sometimes ordered on the mother’s chart or electronic health record. This practice may lead to the inadvertent administration of fetal medications to the mother. We recently learned of a very tragic event that points out the importance of establishing a process to identify the mother and unborn baby as two separate patients—a difficult task given that the unborn baby is typically not a separate registered patient. 

Erythroblastosis fetalis is a severe anemia that develops in an unborn baby due to Rh incompatibility between the baby’s and the mother’s blood. If erythroblastosis fetalis develops, an intrauterine transfusion via the umbilical vein can provide blood to an Rh-positive fetus when fetal blood cells are being destroyed by the mother’s Rh antibodies. Because cannulation of the umbilical vein is difficult, and retention of the catheter during the transfusion may be thwarted by fetal movement, a perinatologist who has experience in performing high-risk procedures may choose to inject a neuromuscular blocking agent intramuscularly into the fetus in utero while using ultrasound guidance. 

In the recent case, an obstetrical resident asked another resident to order a neuromuscular blocking agent for the procedure. The resident ordered the drug in the mother’s medical record, but did not include the dose or route. It wasn’t clear that the drug was intended for intramuscular administration to the fetus in utero. Therefore, the order was processed for the mother, not the baby, and pharmacy dispensed a vial of the paralyzing agent. A medical intern, who was unfamiliar with the procedure and neuromuscular blocking agents in general, administered the drug intravenously to the mother since it had been ordered on the mother’s medical record. Apparently, the intern did not realize that the neuromuscular blocking agent would paralyze the respiratory muscles, and that administration of this class of drugs required concomitant mechanical ventilation. It is believed that the entire vial was administered, not just the small amount intended for the unborn baby. The mother suffered a respiratory arrest, which regrettably was not recognized immediately given prior sedation the mother had received. The mother died and the infant sustained central nervous system (CNS) impairment as a result of this event. 

Although the potential for such an error may seem remote, the history of the ISMP National Medication Errors Reporting Program (ISMP MERP) reveals a multitude of tragic incidents that one might think could never happen again. In the case of erythroblastosis fetalis, the chance of this error is heightened due to the necessity of repeated transfusions. Hospitals with high-risk perinatal departments that perform surgical procedures, blood transfusions, or other procedures in utero should give due consideration to the possibility of inadvertent administration of any medications to the mother that were intended for the fetus. Ordering medication for the fetus on the mother’s medical record creates a significant risk of an error, as illustrated in the recent event. 

To avoid harm, high-risk procedures are always worthy of a “time out” process and independent double checks (www.ismp.org/sc?id=201). A separate account and medical record for the fetus seems appropriate, but there may be obstacles given the baby’s unborn status. Some hospitals enter the orders for the fetus temporarily on a paper form or electronically as “Baby Doe” (or generic name with parent identifier) if the infant’s birth is imminent. The orders are then entered into the infant’s record after birth for permanent documentation and billing. Also, in this case, providing a complete order that included the specific dose and route of administration may have prevented harm to the mother; the specific dose given to the mother intramuscularly would have caused less rapid and profound respiratory depression.

Another strategy is to identify all situations in your hospital where medications may be given to the fetus in utero, then develop order sets that clearly include the dose (or a prompt for a dose), the route of administration, and the intended patient/recipient. Pharmacy preparation and labeling of the product can contribute to safety by assuring a double check of the dose and making it clear that the drug is intended only for the fetus, provided the pharmacy knows the drug is for the fetus; in this case it seems they did not. An anesthesia team should be on “standby” and alerted when the procedure is going to commence. Finally, fetal monitoring along with cardiac and respiratory monitoring for the mother before, during, and after the procedure may facilitate early recognition of an error. 

For those who work in hospitals that perform intrauterine blood transfusions, since this is a very specialized procedure, we would greatly appreciate learning how you are promoting safety during these procedures. Other situations may have similar challenges—such as orders from a neonatologist for specific drugs to be on hand for an unborn baby about to be delivered. Please consider sending an outline of how these processes are carried out to ismpinfo@ismp.org so we can share your safety efforts with others.
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