Press Conference Statement, October 25, 2007
Dr. Novak is professor of pediatrics and vice chair of clinical affairs for the UF College of Medicine Department of Pediatrics
The University of Florida College of Medicine, its Department of Pediatrics and Shands HealthCare express our profound sadness over the death of Sebastian Ferrero, a three-year-old boy who received care in our facilities.
Sebastian died on Wednesday, October 10th, at Shands at the University of Florida medical center.
To his mother, father, younger brother, and other family members, we extend our prayers, thoughts, and deepest sympathies. We take full responsibility for Sebastian’s death and are very, very sorry.
On Monday, October 8th, Sebastian visited the University of Florida Physicians Pediatric Outpatient Clinic and received a growth hormone stimulation test. Sebastian was an extremely bright and healthy boy, but his growth rate was below average for his age. Because of this, physicians were investigating the function of his pituitary gland, which secretes growth hormone.
At the clinic, Sebastian was administered the amino acid arginine, a naturally occurring substance used for testing for growth hormone deficiency, which was dispensed by the Shands Medical Plaza Outpatient Pharmacy. The dose prescribed by Sebastian’s physician was 5.75 grams. Sebastian received 60 grams. Sebastian’s mother inquired about the appropriateness of the dose before the test was initiated.
In the test, an intravenous catheter is inserted into a vein and an arginine solution is infused for thirty minutes. After that, blood samples are taken at thirty-minute intervals for three hours.
About three-quarters of the way through the infusion, Sebastian showed signs of distress and severe headache. Headaches can be a side effect of the procedure. A physician examined Sebastian and the procedure continued. Sebastian was released and his family took him home in the early afternoon.
About 11:30 that evening, Sebastian was taken to the emergency room at Shands AGH by his family. He was vomiting and exhibiting neurological symptoms. He was treated for dehydration and admitted to the hospital.
During the course of the treatment, doctors determined that Sebastian had cerebral edema, which is swelling of the brain. Early Wednesday morning, Sebastian was transferred to the pediatric intensive care unit at Shands at UF medical center. His family was told later that morning that there was no evidence of brain activity and late on Wednesday evening, Sebastian was officially declared brain dead. After the family was advised that diagnostic testing revealed no brain activity on Wednesday morning, they were informed that Sebastian had received an overdose of arginine. Sebastian was removed from life support on Thursday.
Our investigation to date has identified a series of errors that collectively caused this tragic outcome and the family has been made aware of our findings.
In particular, we are evaluating how the arginine prescription was processed at the pharmacy and how it was administered in the clinic. Serious complications from the arginine stimulation procedure, when done correctly, are extremely rare. Therefore, we want to completely understand how and why this tragedy occurred, in order to prevent it, or anything like it, from ever happening again.
We are continuing to investigate the sequence of events that led to the overdose. The results of that investigation will be fully disclosed to Sebastian’s family.
Interim steps we have taken include:
* A nurse and a 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.
* Any medication dispensed from Shands at UF Outpatient Pharmacies for intravenous infusion in a University of Florida Physicians Clinic will be reviewed by a pharmacy manager to 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 indicate both the dose and volume of medication to be administered; that the dose is appropriate for the condition being diagnosed and treated.
* 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.
Unfortunately, these steps cannot undo the tragedy that occurred. Words cannot describe our profound regret for these events. Sebastian, in his short life, touched the lives of many people, including many of us here at the University of Florida and Shands HealthCare. His mother and father, younger brother, grandparents and many other relatives have our sincere condolences.
The family has asked us to relay their request that the media respect their privacy and not attempt to contact them about this matter.