United States Pharmacovigilence Retapamulin-Prescribing
- Conditions
- Skin Infections, Bacterial
- Interventions
- Drug: Co-prescription of retapamulin and topical mupirocin
- Registration Number
- NCT01153880
- Lead Sponsor
- GlaxoSmithKline
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- The study population will consist of all 'eligible members' in the IHCIS database with a valid gender and age record who have at least 1 month enrolment and eligibility of pharmacy benefits.
- Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 66 years and older Retapamulin Age at time of prescription was 66 years and older Age <9 months definitive Co-prescription of retapamulin and topical mupirocin Age at time of prescription was \<9 months Age <9 months uncertain Co-prescription of retapamulin and topical mupirocin Age at time of prescription was uncertain for \<9 months 9 months to 6 years Co-prescription of retapamulin and topical mupirocin Age at time of prescription was 9 months to 6 years 19 to 65 years Co-prescription of retapamulin and topical mupirocin Age at time of prescription was 19 to 65 years 7 to 18 years Co-prescription of retapamulin and topical mupirocin Age at time of prescription was 7 to 18 years 66 years and older Co-prescription of retapamulin and topical mupirocin Age at time of prescription was 66 years and older 19 to 65 years Retapamulin Age at time of prescription was 19 to 65 years 7 to 18 years Retapamulin Age at time of prescription was 7 to 18 years Age <9 months definitive Retapamulin Age at time of prescription was \<9 months Age <9 months uncertain Retapamulin Age at time of prescription was uncertain for \<9 months 9 months to 6 years Retapamulin Age at time of prescription was 9 months to 6 years
- Primary Outcome Measures
Name Time Method Prescription of retapamulin First prescription in database for each calendar year between January 2007 and December 2011
- Secondary Outcome Measures
Name Time Method Prescription for retapamulin and topical mupirocin First same-day prescriptions for both medicines in database for each calendar year between Janaury 2007 and December 2011