NCT01153880

United States Pharmacovigilence Retapamulin-Prescribing

Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Retapamulin, a topical pleuromutilin antibiotic, is the first in a new class of topical antibiotics approved for human use. In the United States (US), retapamulin is approved for the treatment of impetigo in persons nine or more months of age and was launched on 12 April 2007. This five-year study is designed to examine use of retapamulin in the pediatric population less than nine months of age. We will conduct an annual assessment of prescription sales claims for retapamulin using the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database. For each year of reporting, the observed frequencies of the exposure, with or without same-day, co-prescribed sales claim of mupirocin, will be identified. The study objectives are to determine the frequency of retapamulin sales in a representative US population stratified by the designated age group and to determine the frequency of same-day sale of the topical agent, mupirocin.

Detailed description

The IHCIS is Health Insurance Portability and Accountability Act (HIPAA) compliant with encrypted member and provider identifiers; date of birth is restricted to year of birth. Based on year of birth and the prescription sales claim date, age at the time of the prescription(s) will be categorized as less than 9 months (definitive) and less than 9 months (uncertain).

Conditions

• Skin Infections, Bacterial

Interventions

Type	Name	Description
DRUG	Retapamulin	Prescription sales claim of retapamulin
DRUG	Co-prescription of retapamulin and topical mupirocin	Same day prescription sales claims for retapamulin and topical mupirocin

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-06-30
• Last updated: 2013-06-10