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 14±10 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.
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