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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age <9 months definitive | Age at time of prescription was <9 months |
| |
| Age <9 months uncertain | Age at time of prescription was uncertain for <9 months |
| |
| 9 months to 6 years | Age at time of prescription was 9 months to 6 years |
| |
| 7 to 18 years | Age at time of prescription was 7 to 18 years |
| |
| 19 to 65 years | Age at time of prescription was 19 to 65 years |
| |
| 66 years and older |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retapamulin | Drug | Prescription sales claim of retapamulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prescription of retapamulin | First prescription in database for each calendar year between January 2007 and December 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Members with enrollment and phamacy benefits eligibility in the Integrated Health Care Information Services (IHCIS) National Managed Care Benchmarked Database will be assessed annually for prescription sales claims for five years post-launch of retapamulin. The IHCIS is a US national managed care database which is Health Insurance Portability and Accountability Act (HIPAA) compliant and features encrypted member and provider identifiers.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C508887 | retapamulin |
| D016712 | Mupirocin |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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Age at time of prescription was 66 years and older
|
| Co-prescription of retapamulin and topical mupirocin | Drug | Same day prescription sales claims for retapamulin and topical mupirocin |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |