United States Pharmacovigilence Retapamulin-Prescribing

Study Overview
=================
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).

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

Conditions
-----------------
Skin Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: Retapamulin
* Drug: Co-prescription of retapamulin and topical mupirocin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age <9 months definitive<br>Age at time of prescription was <9 months | Drug: Retapamulin<br>* Prescription sales claim of retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescription sales claims for retapamulin and topical mupirocin<br>|
| Age <9 months uncertain<br>Age at time of prescription was uncertain for <9 months | Drug: Retapamulin<br>* Prescription sales claim of retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescription sales claims for retapamulin and topical mupirocin<br>|
| 9 months to 6 years<br>Age at time of prescription was 9 months to 6 years | Drug: Retapamulin<br>* Prescription sales claim of retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescription sales claims for retapamulin and topical mupirocin<br>|
| 7 to 18 years<br>Age at time of prescription was 7 to 18 years | Drug: Retapamulin<br>* Prescription sales claim of retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescription sales claims for retapamulin and topical mupirocin<br>|
| 19 to 65 years<br>Age at time of prescription was 19 to 65 years | Drug: Retapamulin<br>* Prescription sales claim of retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescription sales claims for retapamulin and topical mupirocin<br>|
| 66 years and older<br>Age at time of prescription was 66 years and older | Drug: Retapamulin<br>* Prescription sales claim of retapamulin<br>Drug: Co-prescription of retapamulin and topical mupirocin<br>* Same day prescription sales claims for retapamulin and topical mupirocin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription of retapamulin |  | First prescription in database for each calendar year between January 2007 and December 2011 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Altabax, United States, topical, Mupirocin, Retapamulin, Bactroban