United States Pharmacovigilence Retapamulin-Prescribing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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

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Skin Infections, Bacterial

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Age <9 months definitive

Age at time of prescription was \<9 months

Retapamulin

Intervention Type DRUG

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

Age <9 months uncertain

Age at time of prescription was uncertain for \<9 months

Retapamulin

Intervention Type DRUG

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

9 months to 6 years

Age at time of prescription was 9 months to 6 years

Retapamulin

Intervention Type DRUG

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

7 to 18 years

Age at time of prescription was 7 to 18 years

Retapamulin

Intervention Type DRUG

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

19 to 65 years

Age at time of prescription was 19 to 65 years

Retapamulin

Intervention Type DRUG

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

66 years and older

Age at time of prescription was 66 years and older

Retapamulin

Intervention Type DRUG

Prescription sales claim of retapamulin

Co-prescription of retapamulin and topical mupirocin

Intervention Type DRUG

Same day prescription sales claims for retapamulin and topical mupirocin

Interventions

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Retapamulin

Prescription sales claim of retapamulin

Intervention Type DRUG

Co-prescription of retapamulin and topical mupirocin

Same day prescription sales claims for retapamulin and topical mupirocin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.