Pharmacovigilence for Retapamulin: Age-stratified Monitoring of Prescribed Use in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Prescription of retapamulin
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Membership in IHCIS without a valid gender or age record, enrolment less than 1 month, or ineligibility for pharmacy benefits will be excluded.
研究组 & 干预措施
Age <9 months definitive
Age at time of prescription was <9 months
干预措施: Retapamulin (Drug)
Age <9 months definitive
Age at time of prescription was <9 months
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
Age <9 months uncertain
Age at time of prescription was uncertain for <9 months
干预措施: Retapamulin (Drug)
Age <9 months uncertain
Age at time of prescription was uncertain for <9 months
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
9 months to 6 years
Age at time of prescription was 9 months to 6 years
干预措施: Retapamulin (Drug)
9 months to 6 years
Age at time of prescription was 9 months to 6 years
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
7 to 18 years
Age at time of prescription was 7 to 18 years
干预措施: Retapamulin (Drug)
7 to 18 years
Age at time of prescription was 7 to 18 years
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
19 to 65 years
Age at time of prescription was 19 to 65 years
干预措施: Retapamulin (Drug)
19 to 65 years
Age at time of prescription was 19 to 65 years
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
66 years and older
Age at time of prescription was 66 years and older
干预措施: Retapamulin (Drug)
66 years and older
Age at time of prescription was 66 years and older
干预措施: Co-prescription of retapamulin and topical mupirocin (Drug)
结局指标
主要结局
Prescription of retapamulin
时间窗: First prescription in database for each calendar year between January 2007 and December 2011
次要结局
- 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)