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Retapamulin prescriptions and monitored off-label use
Linda M Mundy1, Tim Sampson, John W Logie
1WorldWide Epidemiology, Quantitative Sciences, GlaxoSmithKline, LLC, Collegeville, PA, USA, linda.m.mundy@gsk.com.
Insights
Retapamulin prescriptions in infants under 9 months were low. This study monitored off-label retapamulin (a topical antibiotic) use in young children, suggesting a need for improved pediatric drug safety reporting.
Area of Science:
- Pediatric Pharmacology
- Infectious Disease Treatment
Background:
- Retapamulin is a topical pleuromutilin antibiotic approved for impetigo and infected traumatic lesions.
- Its use is indicated for adults and children over 9 months old.
Purpose of the Study:
- To monitor retapamulin prescription patterns in children younger than 9 months.
- To assess the frequency of off-label drug use in a vulnerable pediatric population.
Main Methods:
- A 5-year observational study analyzed prescription data from the UK Clinical Practice Research Datalink (CPRD) and USA's Clinformatics™ DataMart Multiplan (IMPACT).
- Prescription events in children under 9 months were identified and quantified.
Main Results:
- In the UK CPRD (2008-2011), 2% of retapamulin prescriptions (3/148) were for infants under 9 months.
- In USA's IMPACT (2007-2011), 3.3% of retapamulin claims (1,951/59,210) were for infants under 9 months.
Conclusions:
- Off-label retapamulin use in infants under 9 months was found to be relatively low.
- The study highlights the need for robust off-label drug reporting schemes to enhance pediatric drug safety.
Introduction:
Retapamulin, a topical pleuromutilin that selectively inhibits bacterial protein synthesis, is approved for treatment of impetigo and secondarily infected traumatic lesions in adults and in children older than 9 months of age.
Objective:
A 5-year study was conducted to monitor prescription use in children younger than 9 months of age.
Methods:
Annual prescription events were monitored in the UK Clinical Practice Research Datalink (CPRD) and the Clinformatics™ DataMart Multiplan (IMPACT), a product of OptumInsight Life Sciences, Inc. (Eden Prairie, MN, USA), from the USA.
Results:
In the CPRD, of 148 prescriptions, three (2 %) were identified in children aged less than 9 months between years 2008 and 2011. In IMPACT, of 59,210 claims for retapamulin in children, 1,951 (3.3 %) were categorized as definitive, or uncertain for, less than 9 months of age between 2007 and 2011.
Conclusion:
Retapamulin prescription events in children aged less than 9 months were relatively low compared with other recent estimations of off-label pediatric medicines. Our report provides a framework for future investigations and discussions that may facilitate off-label reporting schemes and promote pediatric drug safety.
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