United States Pharmacovigilence Retapamulin-Prescribing

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Infections, Bacterial
• Intervention / Treatment: Drug: Retapamulin; Drug: Co-prescription of 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).

• Study Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): June 30, 2010

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: topical; Altabax; United States; Bactroban; Mupirocin; Retapamulin
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Infections; Inflammation; Connective Tissue Diseases; Bacterial Infections and Mycoses; Suppuration; Cellulitis; Skin Diseases, Infectious; Bacterial Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin; Retapamulin
• Other Study ID Numbers: 113158