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Published on: August 30, 2018
Unapproved prescriptions in two pediatric intensive care units in Israel
Vladimir Gavrilov1, Matityahu Berkovitch2, Galina Ling1
1Department of Pediatrics, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Insights
Pediatric intensive care units (PICUs) in Israel frequently use unapproved medications, with over 80% of patients receiving them. This highlights an urgent need to study these off-label and unlicensed drug uses in children.
Area of Science:
- Pediatric intensive care
- Pharmacology
- Drug safety
Background:
- Many medications used in children lack FDA approval due to insufficient clinical trials.
- Unapproved drug use in pediatric populations increases the risk of adverse drug reactions.
Purpose of the Study:
- To evaluate the prevalence of unapproved (off-label and/or unlicensed) medication use in Israeli pediatric intensive care units (PICUs).
Main Methods:
- Retrospective and prospective analysis of medications administered to patients in two PICUs in Israel.
- Inclusion of 158 patient records from Soroka University Medical Center and Assaf Harofe Medical Center.
Main Results:
- Over 80% of patients received unapproved medications, with similar rates in both PICUs.
- Commonly unapproved drug classes included sympathomimetics, sedatives, antibiotics, anti-infectives, antiasthmatics, and acetaminophen.
- Inappropriate age was the most frequent reason for off-label prescribing, followed by dose, indication, and route.
Conclusions:
- A high incidence of unapproved medication prescriptions was observed in Israeli PICUs.
- There is an urgent need for further investigation into the use of these medications in pediatric patients.
Background:
Many medications prescribed to children worldwide have not been approved for pediatric use because the necessary clinical trials have not yet been performed. Children given these drugs have been shown to be at increased risk for adverse drug reactions.
Objective:
The aim of this study was to assess the extent of unapproved (off label and/or unlicensed) use of medications in pediatric intensive care units (PICUs) in Israel.
Methods:
Medications administered to patients treated in the PICUs of Soroka University Medical Center (SMC) and Assaf Harofe Medical Center (AHMC) were reviewed. Analyses were retrospective at SMC and prospective at AHMC.
Results:
The records of 158 patients were included in the study-116 patients at SMC (73.4%; 62 boys, 54 girls; mean [SD] age, 38.9 [50.4] months) and 42 at AHMC (26.6%; 26 boys, 16 girls; mean [SD] age, 63.3 [69.3] months). They received a total of 123 different medications. Sedatives and antibiotics were the most frequently prescribed drug classes at SMC (15.2% and 6.5%, respectively), and antibiotics, acetaminophen, and antiasthmatic drugs were most frequently prescribed at AHMC (14.4%, 13.6%, and 6.8%, respectively). Sympathomimetic drugs, sedatives, and antibiotics were the drugs most commonly prescribed in an unlicensed or off-label manner at SMC (11.4%, 11.4%, and 6.5%, respectively); at AHMC, they were antiinfectives, sympathomimetics, antiasthmatic drugs, and acetaminophen (18.7%, 16.9%, 12.7%, 6.8%, respectively). The percentage of patients receiving unapproved medications (SMC, 93 [80.2%]; AHMC, 38 [90.5%]) and the percentage of unlicensed and off-label prescriptions (SMC, 243 [41.5%]; AHMC, 118 [41.0%], respectively) were similar between the 2 PICUs. Inappropriate age was the most common off-label category, followed by different dose, different indication, and different route.
Conclusion:
The results of this study of unapproved prescriptions in 2 PICUs in Israel show a high number of such prescriptions and indicate an urgent need to investigate the use of those medications in children.
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