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17475

Off-Label Drug Use In the Pediatric Intensive Care Unit

Sunday, October 21, 2012
Room 281-282 (Morial Convention Center)
Susan Sorenson, PharmD, Investigational Pharmacy, Primary Children's Medical Center, Salt Lake City, UT, Ralph A. Lugo, PharmD, Pharmacy Practice, Bill Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN, Franklin Huggins, PharmD, BCPS, Newborn ICU Pharmacy, University of Utah Hospital, Salt Lake City, UT, Jared Cash, PharmD, Pharmacy, Primary Children's Medical Center, Salt Lake City, UT and Robert M. Ward, MD, FAAP, FCP, Pediatrics, University of Utah, Salt Lake City, UT

Purpose: To determine the frequency of off-label medication prescribing in the Pediatric Intensive Care Unit (PICU) at Primary Children's Medical Center (PCMC) in Salt Lake City, Utah

Methods: We conducted a prospective, observational study of all patients admitted to the 32 bed PICU at PCMC from October 2002 to February 2003. Data collected included patient age, diagnosis, medications ordered and indication for each medication order. As patients were discussed on daily bedside medical rounds, pharmacists recorded on the patient specific Medication Administration Record the indication for the medications.

Each drug order was assessed for whether it was used in an on-label or off-label manner. Off-label use was declared when a drug was prescribed for a patient whose age was not listed in the package labeling and no pharmacokinetic (PK) data was listed in the package insert, or if the drug was used for an indication that was not FDA approved. The primary reference sources for determining labeling status were the PDR Electronic Library, Release 2002.3A, the package insert, and Micromedex Healthcare Series. Medication orders for parenteral nutrition, saline and heparin flushes, crystalloid intravenous fluids, herbal products, and vitamin and nutritional supplements were excluded from evaluation. This study received local IRB approval.

Results: The 490 patients ages, 4 days to 17 years were treated with 335 different drugs. Patients were treated with an average of 1410 drugs (range 1-63). 74 medications were used off-label 10 or more times. Off-label treatment was ordered for 96% of patients and 100% of 13-17 year-old patients.

Medications Ordered

(20 Most Frequent)

No. of Orders

No. of Off-label Medication Orders

% of Orders That Were

Off-Label

Morphine

268

268

100%

Potassium chloride

163

163

100%

Ondansetron

144

144

100%

Metoclopramide

167

141

84%

Dopamine

130

130

100%

Fentanyl

191

127

66%

Lorazepam

108

108

100%

Spironolactone

106

106

100%

Nitroprusside

108

103

95%

Cefuroxime

153

102

67%

Dobutamine

90

90

100%

Epinephrine

100

86

86%

Milrinone

86

86

100%

Papaverine

84

84

100%

Hydrocodone/acetaminophen

77

77

100%

Lansoprazole

60

60

100%

Dexamethasone

92

56

61%

Piperacillin/tazobactam

56

56

100%

Nalbuphine

54

54

100%

Albuterol

55

52

95%

Conclusion: Treatment with medications off-label is the rule rather than the exception in the PICU. This exposes the patient to medications that may not have been adequately studied in that age range, in the ordered dose, or for the specific indication.