UF Health Science Center, Shands HealthCare Apologize for Medication Error

University of Florida and Shands HealthCare officials today apologized for the death of a 3-year-old boy from a medication error and announced strict changes in how certain medications are processed in the pharmacy and administered to clinic patients.

At a news conference at UF’s Health Science Center, officials said Sebastian Ferrero died Oct. 10 at Shands at UF medical center, two days after he received care at University of Florida and Shands HealthCare facilities.

“To his mother, father, younger brother, and other family members, we extend our prayers, thoughts, and deepest sympathies,” said Dr. Donald Novak, vice chairman of clinical affairs for the UF College of Medicine department of pediatrics. “We take full responsibility for Sebastian’s death and are very, very sorry.”

Sebastian, an extremely bright and healthy boy, had a scheduled appointment at the University of Florida pediatrics clinic at the Shands Medical Plaza Oct. 8 for a routine growth hormone stimulation test to help physicians evaluate why his growth rate was below average.

At the clinic, Sebastian was administered the amino acid arginine, a naturally occurring substance used for testing for growth hormone deficiency, that was dispensed by the Shands Medical Plaza Outpatient Pharmacy. The dose prescribed by Sebastian’s physician was 5.75 grams. Sebastian received 60 grams.

Officials are reviewing how the arginine prescription was processed at the pharmacy and how it was administered in the clinic. A pharmacist and nurse have been placed on administrative leave.

A moratorium on infusion procedures has also been instituted at all UF clinics pending a quality assessment and the addition of new patient safety measures. Medications for intravenous infusions dispensed from the Shands outpatient pharmacy must now be reviewed by the pharmacy manager.

During the growth hormone stimulation test, arginine is administered to the patient intravenously over a period of 30 minutes. After the infusion is complete, a nurse draws blood from the patient every 30 minutes to test growth hormone levels. Both the test and arginine are considered to be safe under normal circumstances, Novak said.

The Shands Medical Plaza Outpatient Pharmacy, which does not stock arginine, ordered two bottles of the amino acid solution from a supplier for Sebastian’s test at the clinic. Each 300-milliliter bottle contained 30 grams of arginine.

The prescribed dose of 5.75 grams was correctly printed on the bottles, but the bottles were also marked “1 of 2” and “2 of 2,” which may have led clinic staff to think both bottles were needed to provide the necessary dose. The 5.75-gram dose equals to about one-sixth of one bottle. Sebastian’s mother inquired about the appropriateness of the dose before the test was started.

Prior to the infusion and out of the presence of the parents, the nurse verified that the prescribed dose of arginine was correct for a child of Sebastian’s weight and age with a doctor but she failed to reconcile the information about the concentration of the arginine on the manufacturer’s label with the physician’s order. The nurse did not show the doctor the bottles prior to the time the infusion started.

About three-quarters of the way through the infusion, Sebastian showed signs of distress and a severe headache. Headache can be a side effect of the procedure. Sebastian’s father requested that the test be stopped and that a doctor examine Sebastian. A doctor was called to the room and checked the chart but did not check the bottle at that time. Following that examination, the test was completed. Sebastian was released from the clinic and his family took him home that afternoon.

Later that evening, the child became disoriented and began vomiting. His parents brought him to the emergency room at Shands AGH, where he was admitted and treated for dehydration.

Doctors monitored his progress over the next day. He was transported to the pediatric intensive care unit at Shands at UF medical center early on Wednesday, Oct. 10, after it was determined that he was suffering from cerebral edema, or swelling of the brain. The overdose of arginine was discovered Wednesday morning.

UF and Shands leaders are investigating the sequence of events that led to Sebastian’s death and say they have already taken measures to ensure such a tragedy does not occur again.

Interim steps taken include:

* The nurse and the pharmacist directly involved in the case have been placed on administrative leave. Their body of work, inclusive of this incident, will be reviewed.

* A moratorium has been placed on infusion of drugs in all outpatient clinics. A quality assurance review of clinic procedures and personnel training is under way.

* Any UF outpatient clinics that are permitted to infuse drugs must use a double-signoff system involving two qualified professionals to ensure the right patient, the right drug and the right dose.

* Before any medication is dispensed from a Shands Outpatient Pharmacy for intravenous infusion in a University of Florida Physicians Clinic, a pharmacy manager will confirm that the clinic has been reviewed and is allowed to infuse intravenous medications; that the instructions from the physician and the labeling placed on the product clearly indicates both the dose and volume of medication to be administered; and that the dose is appropriate for the condition being treated/diagnosed.

* We are developing a training program for clinic staff who administer infusions. This mandatory training will be completed within the next two weeks.

* The pharmacy will only deliver customized doses of arginine.

* Children scheduled to receive arginine will be treated in an infusion center specifically dedicated to giving infusions of drugs.

* Finally, in addition to the analysis of this particular incident that will be conducted in the coming weeks, the entire team will be examining all medications administered in the clinics, including their source, to determine if dose customization and administration in the infusion center is preferable to in-clinic administration.

“We will review our procedures and add to our safeguards to prevent such errors in the future, and we pledge to leave no stone unturned,” Novak said. “Unfortunately, these steps cannot undo the tragedy that occurred. Words cannot express our profound regret for these events.”

Sebastian’s family has asked University of Florida and Shands HealthCare officials to convey their wish that the media respect their privacy and not attempt to contact them.