| Title |
Evaluation of Switching Patterns in FDA’s Sentinel System: A New Tool to Assess Generic Drugs
|
|---|---|
| Published in |
Drug Safety, August 2018
|
| DOI | 10.1007/s40264-018-0709-4 |
| Pubmed ID | |
| Authors |
Joshua J. Gagne, Jennifer R. Popovic, Michael Nguyen, Sukhminder K. Sandhu, Patty Greene, Rima Izem, Wenlei Jiang, Zhong Wang, Yueqin Zhao, Andrew B. Petrone, Anita K. Wagner, Sarah K. Dutcher |
| Abstract |
Nearly 90% of drugs dispensed in the US are generic products. The aim of this study was to develop and implement a tool for analyzing manufacturer-level drug utilization and switching patterns within the US Food and Drug Administration's Sentinel system. A descriptive tool was designed to analyze data in the Sentinel common data model and was tested with two case studies-metoprolol extended release (ER) and lamotrigine ER-using claims data from four Sentinel data partners. We plotted initiators of each brand and generic product over time. For metoprolol ER, we evaluated rates of switching from generics around the time of manufacturing issues. For lamotrigine ER, we examined rates of switching back to the brand among those who switched from brand to generic. We identified 1,651,285 initiators of metoprolol ER products between July 2008 and September 2015. We observed a large decrease in monthly metoprolol ER initiators (from 25,465 in December 2008 to 13,128 in February 2009), corresponding to recalls by generic manufacturers. We observed simultaneous increases in utilization of the authorized generic and brand products. We identified 4266 initiators of lamotrigine ER with an epilepsy diagnosis between January 2012 and September 2015. Among those who switched from brand to generic, the cumulative incidence of switching back was close to 20% at 2 years. Switchback rates were higher for the first available generic products. This developed tool was able to elucidate novel utilization and switching patterns in two case studies. Such information can be used to support surveillance of generic drugs and biosimilars. |
X Demographics
The data shown below were collected from the profiles of 6 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 5 | 83% |
| Unknown | 1 | 17% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 50% |
| Practitioners (doctors, other healthcare professionals) | 2 | 33% |
| Scientists | 1 | 17% |
Mendeley readers
The data shown below were compiled from readership statistics for 26 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 26 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 6 | 23% |
| Researcher | 6 | 23% |
| Student > Ph. D. Student | 3 | 12% |
| Other | 2 | 8% |
| Student > Doctoral Student | 1 | 4% |
| Other | 2 | 8% |
| Unknown | 6 | 23% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 6 | 23% |
| Medicine and Dentistry | 4 | 15% |
| Biochemistry, Genetics and Molecular Biology | 2 | 8% |
| Economics, Econometrics and Finance | 2 | 8% |
| Nursing and Health Professions | 1 | 4% |
| Other | 5 | 19% |
| Unknown | 6 | 23% |
Attention Score in Context
This research output has an Altmetric Attention Score of 29. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 31 October 2023.
All research outputs
#1,298,329
of 24,713,766 outputs
Outputs from Drug Safety
#112
of 1,773 outputs
Outputs of similar age
#27,435
of 337,964 outputs
Outputs of similar age from Drug Safety
#1
of 24 outputs
Altmetric has tracked 24,713,766 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 94th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,773 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 12.0. This one has done particularly well, scoring higher than 93% of its peers.
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We're also able to compare this research output to 24 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 99% of its contemporaries.