Evaluation of Off-label Prescribing at a Children’s Rehabilitation Center

J Pediatr Pharmacol Ther, 2014 · DOI: · Published: October 1, 2014

Simple Explanation

This study looked at how often medications are prescribed 'off-label' at a children's rehabilitation center. Off-label means the medication is used in a way that's not officially approved, like for a different age group or condition. The researchers wanted to find out which medications, age groups, and medical conditions were most commonly linked to these off-label prescriptions. The study found that off-label prescribing was very common in this setting, and that medications affecting the central nervous system were most often prescribed in this way.

Study Duration

5 Months

Participants

40 patients younger than 16 years

Evidence Level

Prospective observational study

Key Findings

1
57% of medication orders were written off-label.
2
88% of patients received at least one off-label medication.
3
The therapeutic classes most often prescribed off-label were central nervous system agents and anti-infectives.

Research Summary

This prospective observational study evaluated the incidence of off-label prescribing at a pediatric rehabilitation center, finding that 57% of medication orders were written off-label and 88% of patients received at least one off-label medication. The most common reasons for off-label prescribing were use in patients younger than the approved age range (49%) and use for an unapproved indication (48%). Central nervous system agents were the most frequently prescribed off-label therapeutic class, highlighting the need for more research on medications for children undergoing rehabilitation, especially those with brain or spinal cord injuries.

Practical Implications

Further Research

The study highlights the need for more research into the safety and efficacy of medications commonly used off-label in pediatric rehabilitation settings.

Guideline Development

Findings can inform the development of evidence-based guidelines for medication use in pediatric rehabilitation, promoting safer and more effective prescribing practices.

Policy Changes

The high prevalence of off-label prescribing suggests a need for policy changes to incentivize pharmaceutical companies to conduct more pediatric-specific drug trials.

Study Limitations

1
The study was limited by a small sample size, which restricted the ability to analyze correlations between off-label prescribing and various factors.
2
Data collection was complicated by the use of single medications for multiple medical conditions.
3
The study was conducted at a single center, potentially limiting the generalizability of the findings.

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