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Unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel
V Gavrilov1, M Lifshitz, J Levy
1Laboratory of Pediatric Pharmacology, Soroka Medical Center, Beer Sheva, Israel.
Insights
Many pediatric patients receive medications that are not specifically licensed for children (unlicensed) or used outside their approved indications (off-label). A study found that 42% of ambulatory children received such medications, highlighting a significant gap in pediatric drug safety.
Area of Science:
- Pediatric Pharmacology
- Drug Utilization Research
- Public Health
Background:
- Many medications lack established optimal dosage, safety, and efficacy standards for pediatric use.
- A significant number of hospitalized children receive medications off-label or unlicensed.
- The prevalence of off-label and unlicensed medication use in ambulatory pediatric populations is largely unknown.
Purpose of the Study:
- To quantify the extent of unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel.
- To identify patterns and reasons for non-standard medication use in children treated in outpatient settings.
Main Methods:
- Retrospective analysis of 132 outpatient children's medical records.
- Data collected from the General Pediatrics Ambulatory Unit at Soroka Medical Center, Beer Sheva.
- Prescriptions reviewed for adherence to licensing and approved indications.
Main Results:
- Of 222 prescriptions, one-third were either unlicensed (8%) or off-label (26%).
- Common reasons for off-label use included incorrect dosage and age indications.
- All 18 instances of unlicensed use involved modifying licensed drugs, such as crushing tablets for suspensions.
- A total of 42% of children received at least one medication that was off-label and/or unlicensed.
Conclusions:
- Off-label medication use was more prevalent than unlicensed use in this ambulatory pediatric cohort.
- Further research is essential to determine the full scope of unapproved drug use in both hospitalized and ambulatory pediatric patients in Israel.
- Recent Ministry of Health recommendations represent a crucial initial step towards addressing pediatric medication safety internationally.
Background:
Many medications used for children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efficacy. As a result, the majority of children admitted to hospital wards receive medications outside the terms of their license (off-label) or medications that are not specifically licensed for use in children (unlicensed). The extent of unlicensed and off-label medication use in ambulatory children is unknown.
Objective:
To determine the extent of unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel.
Patients And Methods:
We conducted a retrospective analysis of the medical records of 132 outpatient children treated in the General Pediatrics Ambulatory Unit of the Soroka Medical Center, Beer Sheva, in November-December 1998.
Results:
The children's ages ranged from 1 month to 18 years (mean +/- SD 50 +/- 58 months). Of the 222 prescriptions given to these children, one-third were unlicensed (8%) or unlabeled (26%). Different dose and age were the most common categories of off-label medication use. All 18 cases of unlicensed use were due to modification of licensed drugs (tablets were crushed to prepare suspensions). Altogether, 42% of children received medicines that were off-label and/or unlicensed.
Conclusions:
More off-label than unlicensed medications were used. Further investigations are required to establish the extent of unproved drug use in both hospitalized and ambulatory pediatric patients in Israel. Recommendations recently issued by the Ministry of Health's National Council for Child Health and Pediatrics constitute a first step in the Israeli contribution to the international effort demanding testing of medications for children.