United States Pharmacovigilence Retapamulin-Prescribing
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Skin Infections, Bacterial |
Drug: Retapamulin Drug: Co-prescription of retapamulin and topical mupirocin |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States |
- Prescription of retapamulin [ Time Frame: First prescription in database for each calendar year between January 2007 and December 2011 ] [ Designated as safety issue: Yes ]
- Prescription for retapamulin and topical mupirocin [ Time Frame: First same-day prescriptions for both medicines in database for each calendar year between Janaury 2007 and December 2011 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Age <9 months definitive
Age at time of prescription was <9 months
|
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
|
|
Age <9 months uncertain
Age at time of prescription was uncertain for <9 months
|
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
|
|
9 months to 6 years
Age at time of prescription was 9 months to 6 years
|
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
|
|
7 to 18 years
Age at time of prescription was 7 to 18 years
|
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
|
|
19 to 65 years
Age at time of prescription was 19 to 65 years
|
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
|
|
66 years and older
Age at time of prescription was 66 years and older
|
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
|
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).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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.
Exclusion Criteria:
- Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01153880 History of Changes |
| Other Study ID Numbers: | 113158 |
| Study First Received: | June 29, 2010 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Altabax United States topical |
Mupirocin Retapamulin Bactroban |
Additional relevant MeSH terms:
|
Bacterial Infections Skin Diseases, Infectious Infection Skin Diseases Mupirocin Protein Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013